510(k) Report

510(k) · Cleared

Cleared

Bullett Peripheral Infusion Catheter

K931027510(k) TraditionalCleared Feb 4, 1994340-day reviewClass II21 CFR 880.5200

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

Cardio-Dynamics, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Feb 4, 1994 after a 340-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Feb 4, 1994
Review
340 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

19 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK931027 Bullett Peripheral Infusion CatheterCardio-Dynamics, Inc. · 1994
  2. Descendant · cites it directly · 18 of its ownK971619 Microfuse Membrane Infusion CatheterE-Med Corp. · 1998
  3. Descendant · 2 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  4. Descendant · 3 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  5. Descendant · 4 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
  6. Descendant · 4 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12005: 12006: 12007: 22008: 22012: 22014: 12016: 12017: 12018: 12020: 22023: 12025: 12026: 1
1998high 2 (2007) · low 0 (1999)2026

Most influential descendants

Showing 5 of 19 · See all
  • K971619Microfuse Membrane Infusion CatheterE-Med Corp. · 1998 · cites it directly18descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 3 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 4 generations on9descendants
  • K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931027Bullett Peripheral Infusion CatheterCardio-Dynamics, Inc.1994—
+1K971619Microfuse Membrane Infusion CatheterE-Med Corp.1998—
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+4K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—
+4K080901Lbi Embolectomy SystemLumen Biomedical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200510
200610
200720
200820
201220
201410
201610
201710
201810
202020
202310
202510
202610
FIG. 1 — Lineage of K931027, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Planning a device in FOZ? 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 FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971619Microfuse Membrane Infusion CatheterE-Med Corp.199818

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971619 (E-Med Corp., 1998) has gone furthest, with 18 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

More from Cardio-Dynamics, Inc.

4 FDA decisions under this applicant name. See the company

  • K954313Focus PC Balloon Dilatation CatheterCardio-Dynamics, Inc. · 1995
  • K945943CVD Periflow (TM) Balloon Dilatation CatheterCardio-Dynamics, Inc. · 1995
  • K942150CVD Small Vessel Balloon Dilation CatheterCardio-Dynamics, Inc. · 1994

Recent decisions in FOZ

The FOZ category page

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https://510kreport.com/device/K931027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931027: Bullett Peripheral Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931027

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026