510(k) Report

510(k) · Cleared

Cleared

Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.18 G

K122070510(k) SpecialCleared Aug 15, 201230-day reviewClass II21 CFR 870.1250

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

Trireme Medical, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Aug 15, 2012 as substantially equivalent to K082343 (Ymed, Inc., 2008) and 6 other predicates after a 30-day review. Its family tree reaches back 10 generations to 2000. 2 later devices descend from it.

Decided
Aug 15, 2012
Review
30 days
Class
Class II
Product code
LIT
Recalls
None
Predicates
8

Its longest line of descent runs back 10 generations to K001134 (2000). 40 ancestors in all, the oldest K945904 (1995). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2008: 5 other ancestors2012: 1 other ancestor2009: 1 other ancestor2007: 1 other ancestor2006: 3 other ancestors2005: 3 other ancestors1997: 3 other ancestors2004: 2 other ancestors2003: 2 other ancestors2002: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestors1995: 2 other ancestors2013: 1 descendant cleared2021: 1 descendant clearedK001134 · Gazelle Balloon Dilatation Catheter · Boston Scientific Corp · 2000K021735 · Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Scimed, Inc. · 2002 · recalledK050389 · Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Corp · 2005K053116 · Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx · Boston Scientific Corp · 2005K072283 · Dorado Pta Balloon Dilatation Catheter · Bard Peripheral Vascular, Inc. · 2007 · recalledK082579 · Evercross .035 Otw Pta Dilatation Catheter · Ev3, Inc. · 2008 · recalledK101062 · Glider Pta Balloon Catheter · Trireme Medical, Inc. · 2010K103534 · Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire · Trireme Medical, Inc. · 2011K112281 · Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX · Trireme Medical, Inc. · 2011K121402 · Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the Wire) 0.018' G · Trireme Medical, Inc. · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 6 other ancestors4 generations back: 13 other ancestors5 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K121402 · Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the Wire) 0.018' G · Trireme Medical, Inc. · 2012K112281 · Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX · Trireme Medical, Inc. · 2011K103534 · Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire · Trireme Medical, Inc. · 2011K101062 · Glider Pta Balloon Catheter · Trireme Medical, Inc. · 2010K082579 · Evercross .035 Otw Pta Dilatation Catheter · Ev3, Inc. · 2008 · recalledK072283 · Dorado Pta Balloon Dilatation Catheter · Bard Peripheral Vascular, Inc. · 2007 · recalledK053116 · Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx · Boston Scientific Corp · 2005K050389 · Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Corp · 2005K021735 · Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Scimed, Inc. · 2002 · recalledK001134 · Gazelle Balloon Dilatation Catheter · Boston Scientific Corp · 2000−10−50
  1. Root · 10 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
  2. 6 generations between
  3. 3 generations backK103534 Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018…Trireme Medical, Inc. · 2011
  4. 2 generations backK112281 Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire…Trireme Medical, Inc. · 2011
  5. 1 generation backK121402 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
  6. This deviceK122070 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
  7. Descendant · cites it directly · 1 of its ownK130414 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2013
  8. Descendant · 2 generations on · 0 of its ownK213631 Chocolate PTA Balloon CatheterMedtronic, Inc. · 2021
Show all 10 generations
  1. Root · 10 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
  2. 9 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
  3. 8 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
  4. 7 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
  5. 6 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
  6. 5 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
  7. 4 generations backK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
  8. 3 generations backK103534 Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018…Trireme Medical, Inc. · 2011
  9. 2 generations backK112281 Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire…Trireme Medical, Inc. · 2011
  10. 1 generation backK121402 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
  11. This deviceK122070 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc. · 2013 · cites it directly1descendant
  • K213631Chocolate PTA Balloon CatheterMedtronic, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K001134Gazelle Balloon Dilatation CatheterBoston Scientific Corp2000—
−9K021735Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc.200223
−8K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp2005—
−7K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp2005—
−6K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.200715
−5K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.20081
−4K101062Glider Pta Balloon CatheterTrireme Medical, Inc.2010—
−3K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.2011—
−2K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx…Trireme Medical, Inc.2011—
−1K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta…Trireme Medical, Inc.2012—
0 (this device)K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta…Trireme Medical, Inc.2012—
+1K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta…Trireme Medical, Inc.2013—
+2K213631Chocolate PTA Balloon CatheterMedtronic, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199730
200020
200120
200210
200320
200420
200530
200630
200710
200850
200910
201010
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
202110
FIG. 1 — Lineage of K122070, 2000–2021Source: 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), 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.

Planning a device in LIT? 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 LIT device

  1. #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K082343Vascutrak 2, Models: V14 and V18
Summary page 1
…ation Name: Percutaneous Catheter (21 CER 870.1250) Product Code: DQY / LIT 5 10(k) number: Predicate Devices: VascuTrak PTA Dilatation Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K11…
Ymed, Inc.2008—
*K094019Glider Pta Balloon Catheter
Summary page 1
…DQY / LIT 5 10(k) number: Predicate Devices: VascuTrak PTA Dilatation Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K111738, K12067, and K121402) 3. Intended Use The Chocolate PTA Ba…
Trireme Medical, Inc.2010—
*K101062Glider Pta Balloon Catheter
Summary page 1
…QY / LIT 5 10(k) number: Predicate Devices: VascuTrak PTA Dilatation Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K111738, K12067, and K121402) 3. Intended Use The Chocolate PTA Balloon Cat…
Trireme Medical, Inc.2010—
*K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire
Summary page 1
…5 10(k) number: Predicate Devices: VascuTrak PTA Dilatation Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K111738, K12067, and K121402) 3. Intended Use The Chocolate PTA Balloon Catheter is…
Trireme Medical, Inc.2011—
*K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX
Summary page 1
…es: VascuTrak PTA Dilatation Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K111738, K12067, and K121402) 3. Intended Use The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesi…
Trireme Medical, Inc.2011—
*K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)
Summary page 1
…VascuTrak PTA Dilatation Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K111738, K12067, and K121402) 3. Intended Use The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in th…
Trireme Medical, Inc.2011—
Kept off the family treeK120067FDA’s K120067 is Mosaiq Oncology Information System
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Impac Medical Systems, Inc.20123
*K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…
Summary page 1
…tion Catheter (K082343) PTA Balloon Catheter Eamily (K094019, K101062, K103534, K1 12281, K111738, K12067, and K121402) 3. Intended Use The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vascu…
Trireme Medical, Inc.2012—

Also cleared against K082343: 6 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131

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?

  • The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
  • 6 of the 40 ancestors have a recall of any class.
  • Of its descendants, K130414 (Trireme Medical, Inc., 2013) has gone furthest, with 1 descendant of its own.
  • 6 other devices also cite its predicate K082343.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007: 62008: 82009: 72010: 132011: 102012: 192013: 142014: 122015: 192016: 112017: 92018: 62019: 42020: 92021: 42022: 82023: 62024: 62025: 32026 (partial year): 4
2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007: 64 days median2008: 53 days median2009: 29 days median2010: 78 days median2011: 82 days median2012: 29 days median2013: 79 days median2014: 90 days median2015: 112 days median2016: 116 days median2017: 57 days median2018: 118 days median2019: 40 days median2020: 125 days median2021: 61 days median2022: 122 days median2023: 167 days median2024: 43 days median2025: 90 days median2026 (partial year): 205 days median
2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2009: 22010: 12013: 2, 2 Class I2014: 32016: 12018: 22019: 32021: 12024: 22025: 1
2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007: 5772008: 5132009: 6232010: 8092011: 8572012: 1,2772013: 1,2422014: 1,1782015: 1,2792016: 1,5292017: 2,0812018: 2,1882019: 2,4052020: 2,4432021: 2,4922022: 2,1552023: 1,8072024: 1,9132025: 2,073
2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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
20076640577
20088530513
20097292623
201013781809
201110820857
2012192901,277
201314792 (2)1,242
2014129031,178
20151911201,279
20161111611,529
201795702,081
2018611822,188
201944032,405
2020912502,443
202146112,492
2022812202,155
2023616701,807
202464321,913
202539012,073
202642050—

What is it indicated for?

The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.

Indications for use as stated in the FDA summary.

Also cleared against K082343

6 other devices cite the same predicate.

  • K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the…Trireme Medical, Inc. · 2012
  • K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc. · 2012
  • K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc. · 2011
  • K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc. · 2011
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
  • K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc. · 2010

More from Trireme Medical, Inc.

12 FDA decisions under this applicant name. See the company

  • K133633Chocolate Ptca Bolloon CatheterTrireme Medical, Inc. · 2014
  • K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the…Trireme Medical, Inc. · 2013
  • K121681Glider Ptca Balloon CatheterTrireme Medical, Inc. · 2012
  • K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon Catheter (Over the…Trireme Medical, Inc. · 2012
  • K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc. · 2012

Recent decisions in LIT

The LIT category page

  • K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
  • K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026
  • K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026
  • K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025

https://510kreport.com/device/K122070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122070: Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.18 G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122070

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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