Cleared Traditional

K811162 - FLOWLOCK OXYGEN METER

K811162 is an FDA 510(k) clearance for FLOWLOCK OXYGEN METER, manufactured by Lifeguard Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K811162 · Lifeguard Medical Products, Inc. · Anesthesiology device
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May 1981
Decision
10d
Days
Class 2
Risk

K811162 is an FDA 510(k) clearance for the FLOWLOCK OXYGEN METER. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Lifeguard Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5655 - 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.

FDA 510(k) Submission Details - K811162

510(k) Number K811162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 08, 1981
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYJ Device Classification - Class 2, Special Controls

Product Code BYJ Unit, Liquid-oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5655
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 - BYJ Unit, Liquid-oxygen, Portable

All 53
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K811162.
MARK III OXYGEN WALKER SYSTEM
K820836 · Union Carbide Corp. · Apr 1982
UNIT, LIQUID, OXYGEN, PORTABLE
K813453 · Pensee Medical Corp. · Jan 1982
LINDE MARK II
K812536 · Union Carbide Corp. · Sep 1981
LINDE MARK II OXYGEN RESERV. TYPE OR-4
K810732 · Union Carbide Corp. · Mar 1981
LINDE OXYGEN WALKER SYS. MARK II-L
K791902 · Union Carbide Corp. · Oct 1979
TRAVELAIR AND STATIONAIR
K780496 · Cryomed Corp. · Apr 1978
K811162 · FLOWLOCK OXYGEN METER
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