Cleared Traditional

SINGLE USE NON-CONDUCTIVE CIRC. DISCON (K821667) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821667 · Vital Signs, Inc. · Anesthesiology device
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Jun 1982
Decision
17d
Days
Class 2
Risk

K821667 is an FDA 510(k) clearance for the SINGLE USE NON-CONDUCTIVE CIRC. DISCON. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Vital Signs, Inc. (East Rutherford, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K821667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1982
Decision Date June 24, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 139d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 8
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K821667.
NAPA LP-15 Airway Pressure Monitor
K172284 · Drw Medical, LLC · Feb 2018
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
BIRD MEAN AIRWAY PRESSURE MONITOR
K812140 · 3M Company · Aug 1981
TRAVENOL ULTRASONIC NEBULIZER CUPS
K802054 · Travenol Laboratories, S.A. · Dec 1980