510(k) · Cleared

Recalled · Class II · 2014

All Flow Pulmonary Function Filter

K043148510(k) TraditionalCleared Dec 13, 200428-day reviewClass II21 CFR 868.5260Recalls 1

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

Alliance Tech Medical, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Dec 13, 2004 as substantially equivalent to K961914 (Hudson Respiratory Care, Inc., 1996) and 4 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it. It has been recalled once.

Decided: Dec 13, 2004
Review: 28 days
Class: Class II
Product code: CAH
Recalls: 1
Predicates: 5

Its longest line of descent runs back 2 generations to K792097 (1979). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK792097 Dryden Bacteria FilterDryden Corp. · 1979
1 generation backK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
This deviceK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK121382 Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012
Descendant · cites it directly · 0 of its ownK062913 Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012 · cites it directly0descendants
K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K792097	Dryden Bacteria Filter	Dryden Corp.	1979	—
−1	K961914	Bacteria/Viral Filter	Hudson Respiratory Care, Inc.	1996	—
0 (this device)	K043148	All Flow Pulmonary Function Filter	Alliance Tech Medical, Inc.	2004	—
+1	K121382	Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]	Westmed, Inc.	2012	—
+1	K062913	Astraguard Pulmonary Function Filter	Sdi Diagnostics, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	2	0
1995	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2012	1	0

FIG. 1 — Lineage of K043148, 1979–2012Source: 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 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 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K961914	Bacteria/Viral Filter Summary page 2 …uivalence of the Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter to five predicate devices: (1) The Main Flow BacterialNiral PF Filter, K961914, SE letter: 08/14/96. (2) The SpiroSafe Disposable PF Filter, K973314, SE letter: 11/21/97. (3…	Hudson Respiratory Care, Inc.	1996	—
*	K973314	Spirosafe Filter Summary page 2 …dicate devices: (1) The Main Flow BacterialNiral PF Filter, K961914, SE letter: 08/14/96. (2) The SpiroSafe Disposable PF Filter, K973314, SE letter: 11/21/97. (3) The KOKO Disposable PF Filter II, K934475, SE letter: 10/21/93. (4)…	Micro Direct, Inc.	1997	—
*	K934475	Koko Filter II Summary page 2 …/96. (2) The SpiroSafe Disposable PF Filter, K973314, SE letter: 11/21/97. (3) The KOKO Disposable PF Filter II, K934475, SE letter: 10/21/93. (4) The MicroGard Disposable PF Filter, K934272, SE letter: 11/24/93. (5)…	Pulmonary Data Services Inst., Inc.	1993	—
*	K934272	Sensormedics Microgard Microbial Filter Summary page 2 …1/97. (3) The KOKO Disposable PF Filter II, K934475, SE letter: 10/21/93. (4) The MicroGard Disposable PF Filter, K934272, SE letter: 11/24/93. (5) The MultiSPIRO Disposable PF Filter, K951410, SE letter: 04/24/95. 4.5 Description of the…	Sensor Medics Corp.	1993	—
*	K951410	Disposable Pulmonary Function Filter Summary page 2 …SE letter: 10/21/93. (4) The MicroGard Disposable PF Filter, K934272, SE letter: 11/24/93. (5) The MultiSPIRO Disposable PF Filter, K951410, SE letter: 04/24/95. 4.5 Description of the Device: The All Flow Pulmonary Function Filter, manufactured by Alliance Te…	Creative Biomedics, Inc.	1995	—

Also cleared against K961914: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K121382	Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]	Westmed, Inc.	2012	0
K062913	Astraguard Pulmonary Function Filter	Sdi Diagnostics, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 6, 2014	Class II	Z-0714-2020	Employee error	Patients have experienced a bad taste associated with the filters.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K121382 (Westmed, Inc., 2012) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K961914.

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

2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2007high 281 (2011) · low 111 (2009)2026

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

Recalls per year · CAH

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	32
2008	1	—	0	27
2009	4	111	0	18
2010	5	216	2	40
2011	3	281	0	9
2012	3	212	0	16
2013	1	—	1	47
2014	4	250	1	98
2015	2	—	0	51
2016	0	—	0	34
2017	1	—	1	29
2018	0	—	0	33
2019	2	—	0	30
2020	2	—	0	33
2021	2	—	0	56
2022	3	204	6 (6)	67
2023	3	237	0	40
2024	2	—	0	51
2025	0	—	1 (1)	77
2026	2	—	0	—

What is it indicated for?

The Alliance Tech Medical, Inc. All Flow Pulmonary Function 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.

https://510kreport.com/device/K043148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043148: All Flow 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/K043148

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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