Cleared Traditional

K831885 - CODE BLUE MANUAL RESUSCITATOR

K831885 is the FDA 510(k) clearance for CODE BLUE MANUAL RESUSCITATOR by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K831885 · Vital Signs, Inc. · Anesthesiology device
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Sep 1983
Decision
87d
Days
Class 2
Risk

K831885 is an FDA 510(k) clearance for the CODE BLUE MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Vital Signs, Inc. (East Rutherford, US). The FDA issued a Cleared decision on September 8, 1983 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vital Signs, Inc. devices

Submission Details

510(k) Number K831885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date September 08, 1983
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 74
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K831885.
FLOW CONTROLLER
K843223 · Precision Medical, Inc. · Sep 1984
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984
MARK III RESUSCITATOR
K840349 · Ambu, Inc. · Feb 1984
SC-603 TWIN VALVE
K831486 · Instrumentation Industries, Inc. · Aug 1983
BE#1000-INSTANT ON/OFF O2 VALVE
K823408 · Instrumentation Industries, Inc. · Dec 1982
SIEMENS-ELEMA AB AGA REVIVATOR
K822213 · Siemens Elema AB · Oct 1982