510(k) Report

510(k) · Cleared

Cleared

Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]

K121382510(k) TraditionalCleared Dec 6, 2012212-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

Westmed, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Dec 6, 2012 as substantially equivalent to K043148 (Alliance Tech Medical, Inc., 2004) and 4 other predicates after a 212-day review. Its family tree reaches back 3 generations to 1979.

Decided
Dec 6, 2012
Review
212 days
Class
Class II
Product code
CAH
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K792097 (1979). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1995: 1 other ancestor1993: 2 other ancestors1992: 1 other ancestorK792097 · Dryden Bacteria Filter · Dryden Corp. · 1979K961914 · Bacteria/Viral Filter · Hudson Respiratory Care, Inc. · 1996K043148 · All Flow Pulmonary Function Filter · Alliance Tech Medical, Inc. · 2004 · recalled1980199020002010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K043148 · All Flow Pulmonary Function Filter · Alliance Tech Medical, Inc. · 2004 · recalledK961914 · Bacteria/Viral Filter · Hudson Respiratory Care, Inc. · 1996K792097 · Dryden Bacteria Filter · Dryden Corp. · 19790
  1. Root · 3 generations backK792097 Dryden Bacteria FilterDryden Corp. · 1979
  2. 2 generations backK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
  3. 1 generation backK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
  4. This deviceK121382 Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K792097Dryden Bacteria FilterDryden Corp.1979—
−2K961914Bacteria/Viral FilterHudson Respiratory Care, Inc.1996—
−1K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.20041
0 (this device)K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199320
199510
199710
FIG. 1 — Lineage of K121382, 1979–2012Source: 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 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
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What was it cleared against? (5)

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
*K043148All Flow Pulmonary Function Filter
Summary page 2
…establishes the substantial equivalence of the Weatmed, Inc. BlockAide mFilter to five predicate devices: (1) The All Flaw Pulmonary Filter, 1(043148, SE letter: 12/13/04. (2) The SpiroSafe Disposable PP Filter, K(973314, SE letter: 11/21/97. (3) The KO…
Alliance Tech Medical, Inc.20041
*K973314Spirosafe Filter
Summary page 2
…er to five predicate devices: (1) The All Flaw Pulmonary Filter, 1(043148, SE letter: 12/13/04. (2) The SpiroSafe Disposable PP Filter, K(973314, SE letter: 11/21/97. (3) The KOKO( Disposable PF Filter 11, K934475, SE letter: 10/21/93. (4) The Micr…
Micro Direct, Inc.1997—
*K934475Koko Filter II
Summary page 2
…1(043148, SE letter: 12/13/04. (2) The SpiroSafe Disposable PP Filter, K(973314, SE letter: 11/21/97. (3) The KOKO( Disposable PF Filter 11, K934475, SE letter: 10/21/93. (4) The MicraGard Disposable PF Filter, K934272, SE letter: 11/24/93. (5) The Mul…
Pulmonary Data Services Inst., Inc.1993—
*K934272Sensormedics Microgard Microbial Filter
Summary page 2
…er, K(973314, SE letter: 11/21/97. (3) The KOKO( Disposable PF Filter 11, K934475, SE letter: 10/21/93. (4) The MicraGard Disposable PF Filter, K934272, SE letter: 11/24/93. (5) The MultiSPIRO Disposable PP Filter, K(951410, SE letter: 04/24/95. 4.6 Description o…
Sensor Medics Corp.1993—
*K951410Disposable Pulmonary Function Filter
Summary page 2
…K934475, SE letter: 10/21/93. (4) The MicraGard Disposable PF Filter, K934272, SE letter: 11/24/93. (5) The MultiSPIRO Disposable PP Filter, K(951410, SE letter: 04/24/95. 4.6 Description of the Device: The BlockAide"u Filter, manufactured by Westmed, Inc., is a dis…
Creative Biomedics, Inc.1995—

Also cleared against K043148: 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 33 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 1 other device also cites its predicate K043148.

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. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

The Westmed, Inc. BlockAide Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

Indications for use as stated in the FDA summary.

Also cleared against K043148

1 other device cites the same predicate.

  • K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007

More from Westmed, Inc.

8 FDA decisions under this applicant name. See the company

  • K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. · 2016
  • K143148Disposable Pressure Manometer (DPM)Westmed, Inc. · 2015
  • K133057Vibralung Acoustical PercussorWestmed, Inc. · 2014
  • K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 20081 Class I recall
  • K072220Pedi CO2 EasyWestmed, Inc. · 2007

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/K121382 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121382: Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121382

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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