510(k) · Cleared

Cleared

SafeBreath Filter Mouthpiece

K190022510(k) TraditionalCleared Sep 25, 2019264-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

MD Diagnostics Limited · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Sep 25, 2019 as substantially equivalent to K973314 (Micro Direct, Inc., 1997) after a 264-day review. Its family tree reaches back 2 generations to 1992.

Decided: Sep 25, 2019
Review: 264 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K914272 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK914272 Koko SpirometerFerraris Respiratory, Inc. · 1992
1 generation backK973314 Spirosafe FilterMicro Direct, Inc. · 1997
This deviceK190022 SafeBreath Filter MouthpieceMD Diagnostics Limited · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K914272	Koko Spirometer	Ferraris Respiratory, Inc.	1992	—
−1	K973314	Spirosafe Filter	Micro Direct, Inc.	1997	—
0 (this device)	K190022	SafeBreath Filter Mouthpiece	MD Diagnostics Limited	2019	—

FIG. 1 — Lineage of K190022, 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

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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
*	K973314	Spirosafe Filter Summary page 4 …Device classification: II Product code: CAH Classification Panel: General Hospital Predicate Device details Predicate 1: Device name / 510k: SpiroSafe filter (K973314) Manufacturer: Micro Direct Inc, Lewiston, Maine 04240 Further to a review of the MAUDE database – There is no record of any p…	Micro Direct, Inc.	1997	—

Also cleared against K973314: 3 other devices →

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 27 years and passes through 3 companies; a new generation was cleared every 21.8 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K973314.

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. 2019, this device’s year, is highlighted.

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, for use with carbon monoxide monitors. For use by healthcare professionals only.

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/K190022 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190022: SafeBreath Filter Mouthpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190022

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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