510(k) Report

510(k) · Cleared

Cleared

Breeze Digital Inflation Device

K953676510(k) TraditionalCleared Mar 29, 1996235-day reviewClass II21 CFR 870.1650

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

Namic · MAV Syringe, Balloon Inflation

Cleared on Mar 29, 1996 as substantially equivalent to K904275 (North American Instrument Corp., 1991) after a 235-day review. Its family tree reaches back 1 generation to 1991. 10 later devices descend from it.

Decided
Mar 29, 1996
Review
235 days
Class
Class II
Product code
MAV
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K904275 (1991). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2004: 2 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2007: 1 descendant cleared2015: 1 descendant cleared2006: 1 descendant cleared2024: 1 descendant clearedReference device: K902472 · Morse DT Manifold · North American Instrument Corp. · 1990 · Class I recallReference device: K903493 · Namic Contrast Savings Delivery System · North American Instrument Corp. · 1991Reference device: K915078 · Morse Hemostatic Catheter Introducer Set · North American Instrument Corp. · 1992K904275 · Morse Balloon Inflation Device · North American Instrument Corp. · 19911990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K904275 · Morse Balloon Inflation Device · North American Instrument Corp. · 19910
  1. Root · 1 generation backK904275 Morse Balloon Inflation DeviceNorth American Instrument Corp. · 1991
  2. This deviceK953676 Breeze Digital Inflation DeviceNamic · 1996
  3. Descendant · cites it directly · 9 of its ownK022061 Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002
  4. Descendant · 2 generations on · 6 of its ownK040155 Peripheral Cutting BalloonBoston Scientific Corp · 2004
  5. Descendant · 2 generations on · 5 of its ownK051254 Peripheral Cutting BalloonBoston Scientific Ivt · 2005
  6. Descendant · 2 generations on · 5 of its ownK041993 2 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004
  7. Descendant · 3 generations on · 4 of its ownK052038 Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery…Boston Scientific Corporation · 2005 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 22005: 22006: 12007: 12015: 12024: 1
2002high 2 (2004) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K022061Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc. · 2002 · cites it directly9descendants
  • K040155Peripheral Cutting BalloonBoston Scientific Corp · 2004 · 2 generations on6descendants
  • K051254Peripheral Cutting BalloonBoston Scientific Ivt · 2005 · 2 generations on5descendants
  • K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt · 2004 · 2 generations on5descendants
  • K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation · 2005 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904275Morse Balloon Inflation DeviceNorth American Instrument Corp.1991—
0 (this device)K953676Breeze Digital Inflation DeviceNamic1996—
+1K022061Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc.2002—
+2K040155Peripheral Cutting BalloonBoston Scientific Corp2004—
+2K051254Peripheral Cutting BalloonBoston Scientific Ivt2005—
+2K0419932 CM Peripheral Cutting BaloonBoston Scientific Ivt2004—
+3K052038Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery SystemBoston Scientific Corporation20052

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200420
200520
200610
200710
201510
202410
FIG. 1 — Lineage of K953676, 1991–2024Source: 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.

Planning a device in MAV? 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 MAV device

  1. #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K904275Morse Balloon Inflation Device
Summary page 2
…TION Page 42 PREMARKET NOTIFICATION VII. 510(K) Summary (Continued). Biocompatibility testing has been performed on the Morse Balloon Inflation Device (K904275), the Transducer Manifold (K902472), the Contrast Controller (K903493), and the Hemostatic Introducer Sheath (K915078). These dev…
North American Instrument Corp.1991—
*—Merit Monarch Inflation Syringe
Named without a submission number
—
†K902472Morse DT ManifoldNorth American Instrument Corp.1990Class I
†K903493Namic Contrast Savings Delivery SystemNorth American Instrument Corp.1991—
†K915078Morse Hemostatic Catheter Introducer SetNorth American Instrument Corp.1992—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K022061Cvsi Peripheral Balloon Catheter; Cvsi InflaterCryo Vascular Systems, Inc.20029

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?

  • Its one ancestor has no recall.
  • Of its descendants, K022061 (Cryo Vascular Systems, Inc., 2002) has gone furthest, with 9 descendants of its own.

How does its category compare?

All MAV devices

MAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAV

1in 2022

2008: 12011: 12012: 42013: 12014: 22015: 32016: 32022: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAV

69in 2016

2012: 85 days median2015: 116 days median2016: 69 days median
2007high 116 (2015) · low 69 (2016)2026

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

Recalls per year · MAV

4in 2024

2010: 32014: 22016: 12018: 12022: 52024: 4
2007high 5 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAV

66in 2025

2007: 372008: 502009: 992010: 882011: 942012: 2512013: 2452014: 922015: 1212016: 1242017: 2462018: 3002019: 1992020: 1012021: 1862022: 4372023: 2202024: 4202025: 66
2007high 437 (2022) · low 37 (2007)2025

MAUDE reports naming product code MAV, 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
20070—037
20081—050
20090—099
20100—388
20111—094
20124850251
20131—0245
20142—292
201531160121
20163691124
20170—0246
20180—1300
20190—0199
20200—0101
20210—0186
20221—5437
20230—0220
20240—4420
20250—066
20261—0—

What is it indicated for?

These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.

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

More from Namic

8 FDA decisions under this applicant name. See the company

  • K951722Perceptor Compensator Morse ManifoldNamic · 1996
  • K921322Morse Anesthesia ManifoldNamic · 1993
  • K822100High Pressure Contrast Injection LineNamic · 1982
  • K813549Continuous Flush DeviceNamic · 1982
  • K790082Arterial Extension SetNamic · 1979

Recent decisions in MAV

The MAV category page

  • K260035Digital Indeflator INFLANTEUAB Telemedicina · 2026
  • K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock…Medtronic Vascular · 2022
  • K162272Fluent inflation deviceVascular Solutions, Inc. · 2016
  • K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device…Medtronic, Inc. · 2016
  • K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016

https://510kreport.com/device/K953676 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953676: Breeze Digital Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953676

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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