510(k) Report

510(k) · Cleared

Cleared

Jetstream G3 System, Model PV31300, PV Console, Model PVCN100

K101221510(k) SpecialCleared Jun 2, 201030-day reviewClass II21 CFR 870.4875

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pathway Medical Technologies, Inc. · MCW Catheter, Peripheral, Atherectomy

Cleared on Jun 2, 2010 as substantially equivalent to K100462 (Pathway Medical Technologies, Inc., 2010) and 5 other predicates after a 30-day review. Its family tree reaches back 15 generations to 1987. 3 of the 57 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.

Decided
Jun 2, 2010
Review
30 days
Class
Class II
Product code
MCW
Recalls
None
Predicates
6

Its longest line of descent runs back 15 generations to K871011 (1987). 37 ancestors in all, the oldest K780551 (1978). 19 later devices descend from it, 3 citing it directly. 3 of the 57 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2006: 2 other ancestors1999: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1990: 2 other ancestors1989: 1 other ancestor2007: 1 other ancestor1988: 3 other ancestors2005: 1 other ancestor2004: 1 other ancestor2000: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1978: 1 other ancestor2013: 1 descendant cleared2012: 2 descendants cleared2011: 2 descendants cleared2014: 4 descendants cleared2018: 3 descendants cleared, 1 with a Class I recall12016: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2021: 3 descendants cleared, 1 with a Class I recall12025: 1 descendant cleared, 1 with a Class I recall1K871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005×2: 2 generations cleared close together, K053460 (2006), K061063 (2006) ×10: 10 generations cleared close together, K081328 (2008), K082186 (2008), K082664 (2008), K083837 (2009), K090325 (2009), K091509 (2009), K092332 (2009), K093456 (2009), K093918 (2010), K100462 (2010) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 8 other ancestors3 generations back: 4 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors6 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants, 1 with a Class I recall14 generations forward: 5 descendants, 1 with a Class I recall15 generations forward: 2 descendants, 1 with a Class I recall1 K100462 · Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100 · Pathway Medical Technologies, Inc. · 2010K093918 · Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2010K093456 · Jetstream G3 System · Pathway Medical Technologies, Inc. · 2009K092332 · Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K091509 · Jetstream G2 NXT System, Model PV20300 · Pathway Medical Technologies, Inc. · 2009K090325 · Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K083837 · Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console) · Pathway Medical Technologies, Inc. · 2009K082664 · Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100 · Pathway Medical Technologies, Inc. · 2008K082186 · Modification to Pathway PV Atherectomy System · Pathway Medical Technologies, Inc. · 2008K081328 · Pathway PV Atherectomy System · Pathway Medical Technologies, Inc. · 2008K061063 · Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300 · Foxhollow Technologies, Inc. · 2006K053460 · Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800, 05200, 06002, 02406, 04706, 04300, · Fox Hollow Technologies · 2006K043553 · Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706, 04300 · Fox Hollow Technologies · 2005K024243 · Reform Peripheral Catheter System, Model 02200; Reform Peripheral Cathetercatheter, Model 02406 · Fox Hollow Technologies · 2003 · recalledK871011 · Simpson Peripheral Atherocath (TM) · Devices For Vascular Intervention, Inc. · 1987−15−10−50+5
  1. Root · 15 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 11 generations between
  3. 3 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
  4. 2 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
  5. 1 generation backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  6. This deviceK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010
  7. Descendant · cites it directly · 14 of its ownK120242 Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  8. Descendant · cites it directly · 10 of its ownK110626 Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE…Pathway Medical Technologies, Inc. · 2011
  9. Descendant · 2 generations on · 6 of its ownK132682 Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking…Atheromed, Inc. · 2014
  10. Descendant · 2 generations on · 6 of its ownK122916 Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF…Medrad, Inc. · 2012
  11. Descendant · 3 generations on · 5 of its ownK140944 1.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy…Atheromed, Inc. · 2014
Show all 15 generations
  1. Root · 15 generations backK871011 Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc. · 1987
  2. 14 generations backK024243 Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies · 2003 · Recalled
  3. 13 generations backK043553 Silverhawk Peripheral Plaque Excision System, Models 02550,04800…Fox Hollow Technologies · 2005
  4. 12 generations backK053460 Modification to Silverhawk Peripheral Plaque Excision System, Models…Fox Hollow Technologies · 2006
  5. 11 generations backK061063 Modification to: Silverhawk Peripheral Plaque Excision System…Foxhollow Technologies, Inc. · 2006
  6. 10 generations backK081328 Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  7. 9 generations backK082186 Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc. · 2008
  8. 8 generations backK082664 Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc. · 2008
  9. 7 generations backK083837 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  10. 6 generations backK090325 Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and…Pathway Medical Technologies, Inc. · 2009
  11. 5 generations backK091509 Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc. · 2009
  12. 4 generations backK092332 Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and…Pathway Medical Technologies, Inc. · 2009
  13. 3 generations backK093456 Jetstream G3 SystemPathway Medical Technologies, Inc. · 2009
  14. 2 generations backK093918 Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with…Pathway Medical Technologies, Inc. · 2010
  15. 1 generation backK100462 Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010
  16. This deviceK101221 Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc. · 2010

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2011: 22012: 22013: 12014: 42015: 12016: 12017: 12018: 32021: 32025: 1
2011high 4 (2014) · low 0 (2019)2026

Class I recalls in this family

  • K172315 Straub Endovascular System3 generations on · 2018
  • K211738 Rotarex Atherectomy System4 generations on · 2021
  • K242757 Rotarex Atherectomy System5 generations on · 2025

Most influential descendants

Showing 5 of 19 · See all
  • K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012 · cites it directly14descendants
  • K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…Pathway Medical Technologies, Inc. · 2011 · cites it directly10descendants
  • K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc. · 2014 · 2 generations on6descendants
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc. · 2012 · 2 generations on6descendants
  • K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc. · 2014 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K871011Simpson Peripheral Atherocath (TM)Devices For Vascular Intervention, Inc.1987—
−14K024243Reform Peripheral Catheter System, Model 02200; Reform Peripheral…Fox Hollow Technologies20031
−13K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200…Fox Hollow Technologies2005—
−12K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550…Fox Hollow Technologies2006—
−11K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models…Foxhollow Technologies, Inc.2006—
−10K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−9K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.2008—
−8K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.2008—
−7K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−6K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod)…Pathway Medical Technologies, Inc.2009—
−5K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.2009—
−4K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod).…Pathway Medical Technologies, Inc.2009—
−3K093456Jetstream G3 SystemPathway Medical Technologies, Inc.2009—
−2K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control…Pathway Medical Technologies, Inc.2010—
−1K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.2010—
0 (this device)K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.2010—
+1K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.2012—
+1K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System…Pathway Medical Technologies, Inc.2011—
+2K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy…Atheromed, Inc.2014—
+2K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System…Medrad, Inc.2012—
+3K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter…Atheromed, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198830
198910
199020
199110
199310
199510
199620
199710
199910
200020
200410
200510
200620
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201220
201310
201440
201510
201610
201710
201831
202131
202511
FIG. 1 — Lineage of K101221, 1987–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MCW device

  1. #1 K233668 Auryon Atherectomy Catheter 1.5 mm XL…score 17.6 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100
Cleared while this submission was under review
Summary page 3
…== Page 3 === Substantially Equivalent Devices: Pathway Medical cites the fbllowing devices as substantially equivalent predicate devices: * Jetstrearn 03TM System (K100462) * Jetstream G3TM System (1K093456) * Jetstream 03TvM System (1(092332) * Jetstream G3TM L System (K093918) * Jet…
Pathway Medical Technologies, Inc.2010—
*K093456Jetstream G3 System
Summary page 2
…nts on a standard I.V. stand and remains outside the sterile field during the procedure. This 510O(k) is for the same device most recently cleared under 5 10(k) K093456, but with the primary modifications intended to ensure any ingress of aspirated material into the guidewire lumen is minimized. I…
Pathway Medical Technologies, Inc.2009—
*K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…
Summary page 3
…ing devices as substantially equivalent predicate devices: * Jetstrearn 03TM System (K100462) * Jetstream G3TM System (1K093456) * Jetstream 03TvM System (1(092332) * Jetstream G3TM L System (K093918) * Jetstream G2TM System (K083837) * Pathway PVrhI Atherectomy System (KOS 1328)…
Pathway Medical Technologies, Inc.2009—
*K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…
Summary page 3
…predicate devices: * Jetstrearn 03TM System (K100462) * Jetstream G3TM System (1K093456) * Jetstream 03TvM System (1(092332) * Jetstream G3TM L System (K093918) * Jetstream G2TM System (K083837) * Pathway PVrhI Atherectomy System (KOS 1328) Testing Summary: To demonstrate substan…
Pathway Medical Technologies, Inc.2010—
*K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…
Summary page 3
…03TM System (K100462) * Jetstream G3TM System (1K093456) * Jetstream 03TvM System (1(092332) * Jetstream G3TM L System (K093918) * Jetstream G2TM System (K083837) * Pathway PVrhI Atherectomy System (KOS 1328) Testing Summary: To demonstrate substantial equivalence of the modified Jetst…
Pathway Medical Technologies, Inc.2009—
*K081328Pathway PV Atherectomy System
Our reading of the summary gave K051328, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pathway PVrhI Atherectomy System”.
Pathway Medical Technologies, Inc.2008—

Also cleared against K100462: 3 other devices →

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.201214
K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…Pathway Medical Technologies, Inc.201110
K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
  • K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3 months on median.
  • 6 of the 37 ancestors have a recall of any class.
  • Of its descendants, K120242 (Pathway Medical Technologies, Inc., 2012) has gone furthest, with 14 descendants of its own.
  • 3 other devices also cite its predicate K100462.

How does its category compare?

All MCW devices

MCW Catheter, Peripheral, Atherectomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MCW

3in 2025

2007: 52008: 62009: 82010: 62011: 62012: 52013: 52014: 72015: 62016: 52017: 72018: 82019: 32020: 22021: 62022: 62023: 42024: 32025: 32026 (partial year): 1
2007high 8 (2009) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCW

46in 2025

2007: 43 days median2008: 33 days median2009: 27 days median2010: 30 days median2011: 39 days median2012: 29 days median2013: 30 days median2014: 117 days median2015: 30 days median2016: 60 days median2017: 91 days median2018: 103 days median2019: 112 days median2021: 119 days median2022: 69 days median2023: 104 days median2024: 41 days median2025: 46 days median
2007high 119 (2021) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MCW

2in 2024

2007: 22008: 12009: 32010: 12016: 22017: 22021: 2, 2 Class I2022: 2, 2 Class I2023: 12024: 2
2007high 3 (2009) · low 0 (2011)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MCW

677in 2025

2007: 502008: 1152009: 1052010: 1672011: 2042012: 1942013: 1342014: 2102015: 3772016: 4092017: 4152018: 5372019: 6182020: 6312021: 7342022: 5662023: 5742024: 6772025: 677
2007high 734 (2021) · low 50 (2007)2025

MAUDE reports naming product code MCW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007543250
20086331115
20098273105
20106301167
20116390204
20125290194
20135300134
201471170210
20156300377
20165602409
20177912415
201881030537
201931120618
20202—0631
202161192 (2)734
20226692 (2)566
202341041574
20243412677
20253460677
20261—0—

What is it indicated for?

The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K100462

3 other devices cite the same predicate.

  • K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  • K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L SystemPathway Medical Technologies, Inc. · 2011
  • K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod)…Pathway Medical Technologies, Inc. · 2010

More from Pathway Medical Technologies, Inc.

16 FDA decisions under this applicant name. See the company

  • K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc. · 2012
  • K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc. · 2011
  • K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L SystemPathway Medical Technologies, Inc. · 2011
  • K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter and Control Pod)…Pathway Medical Technologies, Inc. · 2010
  • K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc. · 2010

Recent decisions in MCW

The MCW category page

  • K260244Auryon Atherectomy SystemEximo Medical · 2026
  • K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc., · 2025
  • K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics · 2025
  • K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 20251 Class I recall
  • K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc., · 2024

https://510kreport.com/device/K101221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101221: Jetstream G3 System, Model PV31300, PV Console, Model PVCN100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101221

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026