Cleared Traditional

K850151 - L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT

K850151 is an FDA 510(k) clearance for L100B UNIVERSAL & L100A NIGHT PATIENT C..., manufactured by Life Products, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K850151 · Life Products, Inc. · Anesthesiology device
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Jul 1985
Decision
185d
Days
Class 1
Risk

K850151 is an FDA 510(k) clearance for the L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Life Products, Inc. (Boulder, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 185 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Products, Inc. devices

FDA 510(k) Submission Details - K850151

510(k) Number K850151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1985
Decision Date July 19, 1985
Days to Decision 185 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 140d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZO Set, Tubing And Support, Ventilator (w Harness)

All 53
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K850151.
GAS SAMPLING KIT
K861286 · Respiratory Support Products, Inc. · Apr 1986
DISPOSABLE VENTILATOR CIRCUITS
K860879 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
VENTILATOR CIRCUITS (VARIOUS TYPES)
K860880 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
SAF T FLO VENTILATOR TUBING
K850703 · Bivona Medical Technologies · Mar 1985
PATIENT BREATHING CIRCUIT
K843036 · Infrasonics Corp. · Aug 1984
PATIENT TUBING HYTREL SIEMENS-ELEMA
K841657 · Siemens Elema AB · May 1984