Cleared Traditional

K821721 - CLINICAL DATA APNEA DETECTOR

K821721 is an FDA 510(k) clearance for CLINICAL DATA APNEA DETECTOR, manufactured by Clinical Data, Inc.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K821721 · Clinical Data, Inc. · Anesthesiology device
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Jul 1982
Decision
33d
Days
Class 2
Risk

K821721 is an FDA 510(k) clearance for the CLINICAL DATA APNEA DETECTOR. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K821721

510(k) Number K821721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1982
Decision Date July 13, 1982
Days to Decision 33 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
107d faster than avg
Panel avg: 140d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLS Device Classification - Class 2, Special Controls

Product Code FLS Monitor, Apnea, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
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 - FLS Monitor, Apnea, Facility Use

Devices cleared under the same product code (FLS) and FDA review panel - the closest regulatory comparables to K821721.
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