510(k) Report

510(k) · Cleared

Cleared

Bacteria/Viral Filter

K961914510(k) TraditionalCleared Aug 14, 199689-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

Hudson Respiratory Care, Inc. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Aug 14, 1996 as substantially equivalent to K792097 (Dryden Corp., 1979) after an 89-day review. Its family tree reaches back 1 generation to 1979. 9 later devices descend from it.

Decided
Aug 14, 1996
Review
89 days
Class
Class II
Product code
CAH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K792097 (1979). 9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2007: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant clearedK792097 · Dryden Bacteria Filter · Dryden Corp. · 197919801990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K792097 · Dryden Bacteria Filter · Dryden Corp. · 19790
  1. Root · 1 generation backK792097 Dryden Bacteria FilterDryden Corp. · 1979
  2. This deviceK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
  3. Descendant · cites it directly · 3 of its ownK052087 Breathing Filter Bacterial/Viral, Model AG7178Ag Industries · 2005
  4. Descendant · 2 generations on · 2 of its ownK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
  5. Descendant · cites it directly · 2 of its ownK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
  6. Descendant · 3 generations on · 1 of its ownK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010
  7. Descendant · 3 generations on · 0 of its ownK131626 Exceleron Bacterial FiltersExceleron Medical · 2014

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12007: 22009: 12010: 12012: 12014: 1
2004high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all
  • K052087Breathing Filter Bacterial/Viral, Model AG7178Ag Industries · 2005 · cites it directly3descendants
  • K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · 2 generations on2descendants
  • K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · cites it directly2descendants
  • K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries · 2010 · 3 generations on1descendant
  • K131626Exceleron Bacterial FiltersExceleron Medical · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792097Dryden Bacteria FilterDryden Corp.1979—
0 (this device)K961914Bacteria/Viral FilterHudson Respiratory Care, Inc.1996—
+1K052087Breathing Filter Bacterial/Viral, Model AG7178Ag Industries2005—
+2K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.2006—
+1K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.20041
+3K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202…Ag Industries2010—
+3K131626Exceleron Bacterial FiltersExceleron Medical2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200720
200910
201010
201210
201410
FIG. 1 — Lineage of K961914, 1979–2014Source: 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
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.

TypeNumberDeviceApplicantDecidedRecalls
*K792097Dryden Bacteria Filter
Summary page 1
…eathing Circuit Bacterial Filter Common or usual name: breathing filter Predi vice Gibeck product no. 1910 Iso-Gard Depth Filter, also known as the Dryden II Filter K# 792097 Devi ription The Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is a disposable, single patient use breathing filter consisti…
Dryden Corp.1979—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K052087Breathing Filter Bacterial/Viral, Model AG7178Ag Industries20053
K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.20042
K09118570530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral FilterHsiner Co., Ltd.20090
K063526A-M Systems Viromax Viral and Bacterial FilterA-M Systems, Inc.20070

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, K052087 (Ag Industries, 2005) has gone furthest, with 3 descendants of its own.

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

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?

For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Hudson Respiratory Care, Inc.

15 FDA decisions under this applicant name. See the company

  • K031383MODEL 780Hudson Respiratory Care, Inc. · 20033 recalls
  • K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by HrciHudson Respiratory Care, Inc. · 2001
  • K011134Oxygen Supply Tubing, Model 1115Hudson Respiratory Care, Inc. · 2001
  • K010402Smooth-Flo CircuitHudson Respiratory Care, Inc. · 2001
  • K001213Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60Hudson Respiratory Care, Inc. · 2000

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/K961914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961914: Bacteria/Viral Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961914

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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