Cleared Traditional

NELLCOR PURITAN BENNETT GEMINI (K972248) - FDA 510(k) Clearance

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

K972248 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Sep 1997
Decision
88d
Days
Class 2
Risk

K972248 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT GEMINI. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Nellcor Puritan Bennett, Inc. devices

Submission Details

510(k) Number K972248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 16, 1997
Decision Date September 12, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 74
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K972248.
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
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ESPIRT
K001208 · Respironics, Inc. · May 2000
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
POWER PACK 350/BATTERY PACK 351
K923992 · Siemens Medical Solutions USA, Inc. · Apr 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993