510(k) Report

510(k) · Cleared

Cleared

Cpap System and Broncho-Cath W/Cpap System

K912240510(k) TraditionalCleared Aug 22, 199193-day reviewClass II21 CFR 868.5965

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

Mallinckrodt Anesthesia Products · BYE Attachment, Breathing, Positive End Expiratory Pressure

Cleared on Aug 22, 1991 after a 93-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Aug 22, 1991
Review
93 days
Class
Class II
Product code
BYE
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK912240 Cpap System and Broncho-Cath W/Cpap SystemMallinckrodt Anesthesia Products · 1991
  2. Descendant · cites it directly · 0 of its ownK971267 Shiley Extended Length, Disposable Cannula, Tracheostomy Tube…Mallinckrodt Medical · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912240Cpap System and Broncho-Cath W/Cpap SystemMallinckrodt Anesthesia Products1991—
+1K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal…Mallinckrodt Medical1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K912240, 1991–1997Source: 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 BYE? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970

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, K971267 (Mallinckrodt Medical, 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BYE devices

BYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYE

1in 2016

2007: 12008: 12009: 32010: 12011: 32013: 12014: 22016: 1
2007high 3 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYE

117in 2011

2009: 155 days median2011: 117 days median
2007high 155 (2009) · low 117 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BYE

1in 2015

2007: 42008: 22015: 12026 (partial year): 1, 1 Class I
2007high 4 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BYE

7in 2025

2007: 82008: 32009: 12010: 42011: 22012: 62013: 22014: 82015: 42017: 32018: 112019: 52020: 52021: 42022: 102023: 82024: 92025: 7
2007high 11 (2018) · low 0 (2016)2025

MAUDE reports naming product code BYE, 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
20071—48
20081—23
2009315501
20101—04
2011311702
20120—06
20131—02
20142—08
20150—14
20161—00
20170—03
20180—011
20190—05
20200—05
20210—04
20220—010
20230—08
20240—09
20250—07
20260—1 (1)—

More from Mallinckrodt Anesthesia Products

3 FDA decisions under this applicant name. See the company

  • K895875Model 4070 Temperature MonitorMallinckrodt Anesthesia Products · 1989
  • K890484HI-LO Temp General Purpose Temperature ProbeMallinckrodt Anesthesia Products · 1989

Recent decisions in BYE

The BYE category page

  • K160112Besmed PEEP ValveBesmed Health Business Corp · 2016
  • K133957Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014
  • K133210B&B BubblerS & T Medical Technologies, Inc. · 2014
  • K122610Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX SeriesSen MU Technology Co., Ltd. · 2013
  • K112546O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011

https://510kreport.com/device/K912240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912240: Cpap System and Broncho-Cath W/Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912240

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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