Cleared Traditional

K801251 - NON-CONDUCTIVE

K801251 is an FDA 510(k) clearance for NON-CONDUCTIVE, manufactured by Vital Signs, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K801251 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
7d
Days
Class 1
Risk

K801251 is an FDA 510(k) clearance for the NON-CONDUCTIVE, SINGLE USE FACE MASK #55. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Vital Signs, Inc. (East Rutherford, US). The FDA issued a Cleared decision on June 4, 1980 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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

FDA 510(k) Submission Details - K801251

510(k) Number K801251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 04, 1980
Days to Decision 7 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
133d faster than avg
Panel avg: 140d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSJ Mask, Gas, Anesthetic

All 26
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K801251.
NON CONDUCTIVE PEDIATRIC ANES. FACE
K821045 · Vital Signs, Inc. · Apr 1982
OHIO NONCONDUCTIVE RBS TYPE FACE MASK
K810990 · Ohio Medical Products · Apr 1981
NON-CONDUCTIVE ANESTHESIA FACE MASK
K803185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1981
ACCUTRON POLLUTION REDUCER
K790638 · Parker Laboratories, Inc. · May 1979