Cleared Traditional

K860455 - MODEL 9000 RECORDING SYSTEM/RESPIRATION...

K860455 is an FDA 510(k) clearance for MODEL 9000 RECORDING SYSTEM/RESPIRATION..., manufactured by Oxford Medilog, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K860455 · Oxford Medilog, Inc. · Anesthesiology device
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Apr 1986
Decision
55d
Days
Class 2
Risk

K860455 is an FDA 510(k) clearance for the MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Oxford Medilog, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 1, 1986 after a review of 55 days - a notably fast clearance 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: 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 Oxford Medilog, Inc. devices

FDA 510(k) Submission Details - K860455

510(k) Number K860455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1986
Decision Date April 01, 1986
Days to Decision 55 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
85d faster than avg
Panel avg: 140d · This submission: 55d
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 65
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K860455.
INFANT MONITOR
K861484 · Healthdyne, Inc. · May 1986
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986
AS165 RESPIRATION MONITOR
K861743 · Air-Shields, Inc. · May 1986
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · Healthdyne, Inc. · Jan 1986
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · Clinical Data, Inc. · Oct 1985