510(k) · Cleared

Cleared

Spirosafe Filter

K973314510(k) TraditionalCleared Nov 21, 199779-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

Micro Direct, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Nov 21, 1997 as substantially equivalent to K914272 (Ferraris Respiratory, Inc., 1992) after a 79-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.

Decided: Nov 21, 1997
Review: 79 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K914272 (1992). 5 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK914272 Koko SpirometerFerraris Respiratory, Inc. · 1992
This deviceK973314 Spirosafe FilterMicro Direct, Inc. · 1997
Descendant · cites it directly · 2 of its ownK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
Descendant · cites it directly · 0 of its ownK190022 SafeBreath Filter MouthpieceMD Diagnostics Limited · 2019
Descendant · cites it directly · 0 of its ownK121382 Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK062913 Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007
Descendant · cites it directly · 0 of its ownK051279 Caldyne, Inc. Exhalometer EX100, Model EX100Caldyne, Inc. · 2005

Most influential descendants

Showing 5 of 5 · See all

K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · cites it directly2descendants
K190022SafeBreath Filter MouthpieceMD Diagnostics Limited · 2019 · cites it directly0descendants
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
K051279Caldyne, Inc. Exhalometer EX100, Model EX100Caldyne, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914272	Koko Spirometer	Ferraris Respiratory, Inc.	1992	—
0 (this device)	K973314	Spirosafe Filter	Micro Direct, Inc.	1997	—
+1	K043148	All Flow Pulmonary Function Filter	Alliance Tech Medical, Inc.	2004	1
+1	K190022	SafeBreath Filter Mouthpiece	MD Diagnostics Limited	2019	—
+1	K121382	Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]	Westmed, Inc.	2012	—
+2	K062913	Astraguard Pulmonary Function Filter	Sdi Diagnostics, Inc.	2007	—
+1	K051279	Caldyne, Inc. Exhalometer EX100, Model EX100	Caldyne, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2007	1	0
2012	1	0
2019	1	0

FIG. 1 — Lineage of K973314, 1992–2019Source: 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? (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
*	K914272	Koko Spirometer Summary page 1 …ted use: David R. Staszak, President SpiroSafe Filter Disposable bacterial/viral filter 73 CAH - Filter, bacterial Disposable bacterial/viral filter PDSI KoKo Filter - K914272 A disposable bacterial/viral filter used in pulmonary function testing The intended device filters possible bacteria and viruse…	Ferraris Respiratory, Inc.	1992	—

Also cleared against K914272: 1 other device →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K043148	All Flow Pulmonary Function Filter	Alliance Tech Medical, Inc.	2004	2
K190022	SafeBreath Filter Mouthpiece	MD Diagnostics Limited	2019	0
K121382	Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]	Westmed, Inc.	2012	0
K051279	Caldyne, Inc. Exhalometer EX100, Model EX100	Caldyne, Inc.	2005	0

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, K043148 (Alliance Tech Medical, Inc., 2004) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K914272.

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?

To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing

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/K973314 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973314: Spirosafe Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973314

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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