510(k) · Cleared

Cleared

Filter

K970102510(k) TraditionalCleared Jun 24, 1997162-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

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

Cleared on Jun 24, 1997 as substantially equivalent to K833066 (Dryden Corp., 1983) and 2 other predicates after a 162-day review. Its family tree reaches back 1 generation to 1983.

Decided: Jun 24, 1997
Review: 162 days
Class: Class II
Product code: CAH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K833066 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK833066 Dryden Mini Bacteria FilterDryden Corp. · 1983
This deviceK970102 FilterPromedic, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K833066	Dryden Mini Bacteria Filter	Dryden Corp.	1983	—
0 (this device)	K970102	Filter	Promedic, Inc.	1997	—

Other ancestors by year cleared

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

FIG. 1 — Lineage of K970102, 1983–1997Source: 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? (3)

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
*	K833066	Dryden Mini Bacteria Filter Summary page 1 …JUN 2 4 1097 ’ Fax - (317) 335-9270 Paul E. Dryden, President Filter Breathing circuit filter Filter, bacterial, breathing circuit Filter Dryden (Gibeck-Dryden) - K833066 Med-Plastics - K930760 Engstrom - wye filter - K954194 Device Description: A filter with a translucent housing and filter medi…	Dryden Corp.	1983	—
*	K930760	Med-Plastics Intl., Inc. Breathing Filter Summary page 1 …(317) 335-9270 Paul E. Dryden, President Filter Breathing circuit filter Filter, bacterial, breathing circuit Filter Dryden (Gibeck-Dryden) - K833066 Med-Plastics - K930760 Engstrom - wye filter - K954194 Device Description: A filter with a translucent housing and filter media which connects to the…	Med-Plastics Intl., Inc.	1993	—
*	K954194	Disposable Hme/Filter Summary page 1 …resident Filter Breathing circuit filter Filter, bacterial, breathing circuit Filter Dryden (Gibeck-Dryden) - K833066 Med-Plastics - K930760 Engstrom - wye filter - K954194 Device Description: A filter with a translucent housing and filter media which connects to the patient connector and the circu…	Engstrom Medical	1995	—

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?

None of the 3 ancestors has a recall.

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 provide filtration for reducing possible contamination between patient and equipment.

Environment of use: Hospital - OR, anesthesia, transport, PACU, manual resuscitators, and ICU

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/K970102 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970102: Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970102

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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