Cleared Traditional

K852515 - ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR

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

K852515 · Alternative Design Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K852515

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.

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 109
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K852515.
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · Aequitron Medical, Inc. · Aug 1985
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · Edentec Corp. · Jul 1985
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
RESPIRATION & HEART RATE MONITOR 530
K843681 · Tri-Med, Inc. · Dec 1984
INFANT MONITOR 16900
K843546 · Healthdyne, Inc. · Oct 1984
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983