Cleared Traditional

K910947 - NEV-10 NEGATIVE PRESSURE VENTILATOR

K910947 is the FDA 510(k) clearance for NEV-10 NEGATIVE PRESSURE VENTILATOR by Lifecare Services, Inc.. It is a Class 2 Anesthesiology device (product code BYT) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K910947 · Lifecare Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
89d
Days
Class 2
Risk

K910947 is an FDA 510(k) clearance for the NEV-10 NEGATIVE PRESSURE VENTILATOR. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Lifecare Services, Inc. (Lafayette, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5935 - 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 Lifecare Services, Inc. devices

Submission Details

510(k) Number K910947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date June 03, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5935
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 - BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)

Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K910947.
HAYEK OSCILLATOR(TM)
K924341 · Respironics, Inc. · Jul 1993
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
K905530 · Puritan Bennett Corp. · Mar 1991
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · Respironics, Inc. · Dec 1989
Q101 DIAGNOSTIC SPIROMETER
K863300 · Quinton, Inc. · Nov 1986