Cleared Traditional

K821667 - SINGLE USE NON-CONDUCTIVE CIRC. DISCON

K821667 is the FDA 510(k) clearance for SINGLE USE NON-CONDUCTIVE CIRC. DISCON by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code CAP) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K821667 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · 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 28
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K821667.
AN PRESSURE MONITOR
K852826 · Ferguson Medical · Dec 1985
DRAGER BAROMED
K840279 · Draeger Medical, Inc. · Mar 1984
MONAGHAN'S PRESSURE ALARM
K821649 · Monaghan Medical Corp. · Aug 1982
BIRD MEAN AIRWAY PRESSURE MONITOR
K812140 · 3M Company · Aug 1981
MEAN PRESSURE MONITOR
K810255 · Healthdyne, Inc. · Feb 1981
MONITOR, AIRWAY PRESSURE
K802955 · Novametrix Medical Systems, Inc. · Dec 1980