Cleared Traditional

K852515 - ACCESSORY VENTILLARY(BREATHING) FREQUEN...

K852515 is the FDA 510(k) clearance for ACCESSORY VENTILLARY(BREATHING) FREQUEN... by Alternative Design Systems, Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K852515 · Alternative Design Systems, Inc. · Anesthesiology device
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Jun 1985
Decision
11d
Days
Class 2
Risk

K852515 is an FDA 510(k) clearance for the ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Alternative Design Systems, Inc. (Carlstadt, US). The FDA issued a Cleared decision on June 24, 1985 after a review of 11 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 Alternative Design Systems, Inc. devices

Submission Details

510(k) Number K852515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1985
Decision Date June 24, 1985
Days to Decision 11 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K852515.
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · Nihon Kohden America, Inc. · Feb 1987
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · Honeywell, Inc. · Oct 1981
NEO NATAL RESPIRATION FUNCTION BLOCK
K810175 · Honeywell, Inc. · Mar 1981