510(k) Report

510(k) · Decided

Recalled · Class II · 2012

General Anesthesia System

K944949510(k) TraditionalDecided Nov 14, 199438-day reviewClass I21 CFR 868.5560Recalls 1

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

Vital Signs, Inc. · BTK Strap, Head, Gas Mask

Cleared on Nov 14, 1994 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Nov 14, 1994
Review
38 days
Class
Class I
Product code
BTK
Recalls
1
Predicates
0

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

FIG. 1 — Lineage of K944949Source: FDA 510(k) database · 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 BTK? 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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 17, 2012Class IIZ-0407-2013Device DesignThere is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

No ancestor or descendant has a Class I recall.

How does its category compare?

All BTK devices

BTK Strap, Head, Gas Mask: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTK

FDA has decided no BTK device since 2007.

Median 510(k) review, days · BTK

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

Recalls per year · BTK

No recall names BTK since 2007.

Adverse event reports per year · BTK

1in 2021

2008: 12012: 112013: 12014: 12016: 22017: 22019: 12020: 22021: 1
2007high 11 (2012) · low 0 (2007)2025

MAUDE reports naming product code BTK, 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—01
20090—00
20100—00
20110—00
20120—011
20130—01
20140—01
20150—00
20160—02
20170—02
20180—00
20190—01
20200—02
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Vital Signs, Inc.

75 FDA decisions under this applicant name. See the company

  • K112902Enflow IV Fluid WarmerVital Signs, Inc. · 2012
  • K041309Imask TMVital Signs, Inc. · 2004
  • K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
  • K022402Disposable Pressure ManometerVital Signs, Inc. · 2002
  • K021315Sure-LokVital Signs, Inc. · 2002

Recent decisions in BTK

The BTK category page

  • K914335Strap, Head, Gas MaskVital Signs, Inc. · 1992
  • K854537HeadstrapLife Design Systems, Inc. · 1985
  • K853573Medipart Face Mask Headstrap MP-9100Medipart Jerry Alexander · 1985
  • K831008Head StrapMedovations, Inc. · 1983
  • K810991HeadstrapRespironics, Inc. · 1981

https://510kreport.com/device/K944949 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944949: General Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944949

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