Cleared Traditional

K983449 - GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

K983449 is an FDA 510(k) clearance for GEREONICS ULTRA-PIEZO RESPIRATORY EFFOR..., manufactured by Gereonics, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K983449 · Gereonics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
131d
Days
Class 2
Risk

K983449 is an FDA 510(k) clearance for the GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Gereonics, Inc. (Fallbrook, US). The FDA issued a Cleared decision on February 8, 1999 after a review of 131 days - within the typical 510(k) review window.

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 - K983449

510(k) Number K983449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1998
Decision Date February 08, 1999
Days to Decision 131 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 140d · This submission: 131d
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 118
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K983449.
ULTIMA SMARTBELT, MODEL 0560
K001743 · Braebon Medical Corp. · Aug 2000
RESPIRATORY BELT SENSOR, MODEL 6000S
K001030 · Dymedix, Inc. · May 2000
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411 · Gereonics, Inc. · Apr 1999
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K981725 · Optovent, Inc. · Feb 1999
ULTIMA AIRFLOW PRESSURE SENSOR
K984431 · Braebon Medical Corp. · Dec 1998
ULTIMA AIRFLOW SENSOR, 0510
K981445 · Braebon Medical Corp. · Oct 1998