Cleared Traditional

K851337 - 502 RESUSCITATORY INHALATOR VALVE

K851337 is an FDA 510(k) clearance for 502 RESUSCITATORY INHALATOR VALVE, manufactured by Life Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K851337 · Life Support Products, Inc. · Anesthesiology device
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May 1985
Decision
42d
Days
Class 2
Risk

K851337 is an FDA 510(k) clearance for the 502 RESUSCITATORY INHALATOR VALVE. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Anaheim, US). The FDA issued a Cleared decision on May 15, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K851337

510(k) Number K851337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1985
Decision Date May 15, 1985
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K851337.
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
K862830 · Pneupac , Ltd. · Oct 1986
IMPACT MODELS 701, 702 AND 703
K861272 · Impact Instrumentation, Inc. · May 1986
SG-066 OXYGEN ENRICHMENT KIT
K860077 · Instrumentation Industries, Inc. · Feb 1986
PNEUPAC OXYGEN THERAPY UNIT
K792453 · Pneupac , Ltd. · Feb 1980