Cleared Traditional

K902916 - PRECISION MEDICAL NEB BLOCK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K902916 · Precision Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
20d
Days
Class 1
Risk

K902916 is an FDA 510(k) clearance for the PRECISION MEDICAL NEB BLOCK. Classified as Flowmeter, Calibration, Gas (product code BXY), Class I - General Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on July 23, 1990 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2350 - 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 Precision Medical, Inc. devices

Submission Details

510(k) Number K902916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date July 23, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 139d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXY Flowmeter, Calibration, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2350
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.