Cleared Traditional

K781158 - ALARM UNIT, BATTERY OPERATED

K781158 is an FDA 510(k) clearance for ALARM UNIT, manufactured by Thompson Respiration Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K781158 · Thompson Respiration Products, Inc. · Anesthesiology device
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Dec 1978
Decision
166d
Days
Class 2
Risk

K781158 is an FDA 510(k) clearance for the ALARM UNIT, BATTERY OPERATED. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Thompson Respiration Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1978 after a review of 166 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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.

FDA 510(k) Submission Details - K781158

510(k) Number K781158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1978
Decision Date December 18, 1978
Days to Decision 166 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 140d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 130
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K781158.
RESPIRATION FUNCTION BLOCKS
K810174 · Honeywell, Inc. · Mar 1981
ECG/RESPIRATION STIMULATOR
K802205 · Healthdyne, Inc. · Oct 1980
PDS MODEL 3000 ADULT RESPIRATION MODULE
K802046 · General Electric Co. · Sep 1980
GOWN, SURGICAL, SURGINE
K770250 · Surgikos, Inc. · Mar 1977
MONITOR, RESPIRATORY (CPAP)
K760339 · Sherwood Medical Industries · Oct 1976
RESPIRATORY SUPPORT SYSTEM, NEONATAL
K760340 · Sherwood Medical Industries · Aug 1976
K781158 · ALARM UNIT, BATTERY OPERATED
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