510(k) Report

510(k) · Cleared

Cleared

Aerochamber

K872037510(k) TraditionalCleared Jul 24, 198758-day reviewClass I21 CFR 868.5620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Monaghan Medical Corp. · BYP Mouthpiece, Breathing

Cleared on Jul 24, 1987 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Jul 24, 1987
Review
58 days
Class
Class I
Product code
BYP
Recalls
None
Predicates
0

5 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared2013: 1 descendant cleared1996: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK872037 AerochamberMonaghan Medical Corp. · 1987
  2. Descendant · cites it directly · 1 of its ownK960593 Smartmist Asthma Managment System, Smartmist, Model Number…Aradigm Corp. · 1996
  3. Descendant · cites it directly · 0 of its ownK130598 Inspirachamber Anti-Static Valved Holding ChamberInspirx, Inc. · 2013
  4. Descendant · 2 generations on · 0 of its ownK051284 MD TurboRespirics, Inc. · 2005
  5. Descendant · cites it directly · 0 of its ownK020944 Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc. · 2002
  6. Descendant · cites it directly · 0 of its ownK964130 Aerogear Asthma Action KitMonaghan Medical Corp. · 1997

Most influential descendants

Showing 5 of 5 · See all
  • K960593Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry…Aradigm Corp. · 1996 · cites it directly1descendant
  • K130598Inspirachamber Anti-Static Valved Holding ChamberInspirx, Inc. · 2013 · cites it directly0descendants
  • K051284MD TurboRespirics, Inc. · 2005 · 2 generations on0descendants
  • K020944Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc. · 2002 · cites it directly0descendants
  • K964130Aerogear Asthma Action KitMonaghan Medical Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K872037AerochamberMonaghan Medical Corp.1987—
+1K960593Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist…Aradigm Corp.1996—
+1K130598Inspirachamber Anti-Static Valved Holding ChamberInspirx, Inc.2013—
+2K051284MD TurboRespirics, Inc.2005—
+1K020944Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc.2002—
+1K964130Aerogear Asthma Action KitMonaghan Medical Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
200210
200510
201310
FIG. 1 — Lineage of K872037, 1987–2013Source: 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 BYP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K960593Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry…Aradigm Corp.19961
K130598Inspirachamber Anti-Static Valved Holding ChamberInspirx, Inc.20130
K020944Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc.20020
K964130Aerogear Asthma Action KitMonaghan Medical Corp.19970

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, K960593 (Aradigm Corp., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All BYP devices

BYP Mouthpiece, Breathing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYP

FDA has decided no BYP device since 2007.

Median 510(k) review, days · BYP

Too few BYP 510(k)s in any year since 2007 to give a median.

Recalls per year · BYP

No recall names BYP since 2007.

Adverse event reports per year · BYP

1in 2025

2010: 22015: 12016: 22019: 12023: 12025: 1
2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code BYP, 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
20070—00
20080—00
20090—00
20100—02
20110—00
20120—00
20130—00
20140—00
20150—01
20160—02
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—01
20240—00
20250—01
20260—0—

More from Monaghan Medical Corp.

33 FDA decisions under this applicant name. See the company

  • K123945Strive Dual Zone Peak Flow MeterMonaghan Medical Corp. · 2013
  • K031514Modification to Trupeak Peak Flow MeterMonaghan Medical Corp. · 2003
  • K023097Truezone Peak Flow MeterMonaghan Medical Corp. · 2003
  • K012939Aerovent II CHC Collapsible Holding ChamberMonaghan Medical Corp. · 2001
  • K991212Modification to Truzone Peak Flow MeterMonaghan Medical Corp. · 1999

Recent decisions in BYP

The BYP category page

  • K955657North State Plastics Respiratory MouthpieceNorth State Plastics, Inc. · 1996
  • K944512Truzone PFM Disposable MouthpieceMonaghan Medical Corp. · 1994
  • K893791Breathing MouthpieceDiemolding Corp. · 1989
  • K865093Safe-T-Shield MouthpieceMedi Nuclear Corp., Inc. · 1987
  • K863049Inhalation AidBoehringer Ingelheim Pharmaceuticals, Inc. · 1986

https://510kreport.com/device/K872037 · printed Nov 5, 2026

Cite this page

510(k) Report. “K872037: Aerochamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K872037

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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