510(k) · Cleared

Cleared

MMS PTA Balloon Catheter

K152934510(k) TraditionalCleared Apr 25, 2016203-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

Micro Medical Solutions, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Apr 25, 2016 as substantially equivalent to K122940 (Cook, Inc., 2013) after a 203-day review. Its family tree reaches back 2 generations to 2009.

Decided: Apr 25, 2016
Review: 203 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K090822 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK090822 Advance 14RX Rapid Exchange Pta Balloon CatheterCook, Inc. · 2009
1 generation backK122940 Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model…Cook, Inc. · 2013
This deviceK152934 MMS PTA Balloon CatheterMicro Medical Solutions, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K090822	Advance 14RX Rapid Exchange Pta Balloon Catheter	Cook, Inc.	2009	—
−1	K122940	Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3	Cook, Inc.	2013	—
0 (this device)	K152934	MMS PTA Balloon Catheter	Micro Medical Solutions, Inc.	2016	—

FIG. 1 — Lineage of K152934, 2009–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K122940	Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3 Summary page 4 …Class II Product Code: LIT Predicate Devices: Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter (K122940) Contact Greg Mathison VP Regulatory, Clinical & Quality Date:…	Cook, Inc.	2013	—

Also cleared against K122940: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 7 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K122940.

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. 2016, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

What is it indicated for?

The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K152934 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152934: MMS PTA Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152934

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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