510(k) Report

510(k) · Cleared

Cleared

Dryden Bacteria Filter

K792097510(k) TraditionalCleared Nov 13, 197926-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

Dryden Corp. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Nov 13, 1979 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Nov 13, 1979
Review
26 days
Class
Class II
Product code
CAH
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2009: 1 descendant cleared2007: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared19801990200020102020
  1. This deviceK792097 Dryden Bacteria FilterDryden Corp. · 1979
  2. Descendant · cites it directly · 9 of its ownK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
  3. Descendant · 2 generations on · 3 of its ownK052087 Breathing Filter Bacterial/Viral, Model AG7178Ag Industries · 2005
  4. Descendant · 3 generations on · 2 of its ownK061426 Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25…Porous Media Corp. · 2006
  5. Descendant · 2 generations on · 2 of its ownK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
  6. Descendant · 4 generations on · 1 of its ownK091363 Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950…Ag Industries · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1996: 12004: 12005: 12006: 12007: 22009: 12010: 12012: 12014: 1
1996high 2 (2007) · low 0 (1997)2026

Most influential descendants

Showing 5 of 10 · See all
  • K961914Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996 · cites it directly9descendants
  • K052087Breathing Filter Bacterial/Viral, Model AG7178Ag Industries · 2005 · 2 generations on3descendants
  • K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp. · 2006 · 3 generations on2descendants
  • K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · 2 generations on2descendants
  • K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205…Ag Industries · 2010 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K792097Dryden Bacteria FilterDryden Corp.1979—
+1K961914Bacteria/Viral FilterHudson Respiratory Care, Inc.1996—
+2K052087Breathing Filter Bacterial/Viral, Model AG7178Ag Industries2005—
+3K061426Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47Porous Media Corp.2006—
+2K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.20041
+4K091363Compressor Filter, Models AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202…Ag Industries2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200410
200510
200610
200720
200910
201010
201210
201410
FIG. 1 — Lineage of K792097, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961914Bacteria/Viral FilterHudson Respiratory Care, Inc.19969

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?

  • Of its descendants, K961914 (Hudson Respiratory Care, Inc., 1996) has gone furthest, with 9 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—
Cite this page

510(k) Report. “K792097: Dryden Bacteria Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K792097

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026