510(k) Report

510(k) · Cleared

Cleared

Disposable Pulmonary Function Filter

K951410510(k) TraditionalCleared Apr 24, 199528-day reviewClass II21 CFR 868.5260

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

Creative Biomedics, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Apr 24, 1995 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 24, 1995
Review
28 days
Class
Class II
Product code
CAH
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2004: 2 descendants cleared2007: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951410 Disposable Pulmonary Function FilterCreative Biomedics, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
  3. Descendant · cites it directly · 0 of its ownK121382 Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012
  4. Descendant · 2 generations on · 0 of its ownK062913 Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007
  5. Descendant · cites it directly · 0 of its ownK033518 Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103Custom Plastic Products · 2004

Most influential descendants

Showing 4 of 4 · See all
  • K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · cites it directly2descendants
  • K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012 · cites it directly0descendants
  • K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007 · 2 generations on0descendants
  • K033518Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103Custom Plastic Products · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951410Disposable Pulmonary Function FilterCreative Biomedics, Inc.1995—
+1K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.20041
+1K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc.2012—
+2K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc.2007—
+1K033518Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103Custom Plastic Products2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200710
201210
FIG. 1 — Lineage of K951410, 1995–2012Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAH? 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 CAH device

  1. #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.20042
K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc.20120
K033518Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103Custom Plastic Products20040

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, K043148 (Alliance Tech Medical, Inc., 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All CAH devices

CAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAH

2in 2024

2007: 22008: 12009: 42010: 52011: 32012: 32013: 12014: 42015: 22017: 12019: 22020: 22021: 22022: 32023: 32024: 22026 (partial year): 2
2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2009: 111 days median2010: 216 days median2011: 281 days median2012: 212 days median2014: 250 days median2022: 204 days median2023: 237 days median
2007high 281 (2011) · low 111 (2009)2026

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

Recalls per year · CAH

1in 2025

2010: 22013: 12014: 12017: 12022: 6, 6 Class I2025: 1, 1 Class I
2007high 6 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · CAH

77in 2025

2007: 322008: 272009: 182010: 402011: 92012: 162013: 472014: 982015: 512016: 342017: 292018: 332019: 302020: 332021: 562022: 672023: 402024: 512025: 77
2007high 98 (2014) · low 9 (2011)2025

MAUDE reports naming product code CAH, 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
20072—032
20081—027
20094111018
20105216240
2011328109
20123212016
20131—147
20144250198
20152—051
20160—034
20171—129
20180—033
20192—030
20202—033
20212—056
202232046 (6)67
20233237040
20242—051
20250—1 (1)77
20262—0—

More from Creative Biomedics, Inc.

4 FDA decisions under this applicant name. See the company

  • K964939The Portable Family - Medi-Facts DX1 Portable Lite and DX1 Portable PlusCreative Biomedics, Inc. · 1997
  • K951157DX1-PortableCreative Biomedics, Inc. · 1995
  • K951227DX1Creative Biomedics, Inc. · 1995

Recent decisions in CAH

The CAH category page

  • K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026
  • K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026
  • K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
  • K222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd. · 2024
  • K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc. · 2023

https://510kreport.com/device/K951410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951410: Disposable Pulmonary Function Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951410

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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