Cleared Traditional

K990177 - NELLCOR PURITAN BENNETT ACHIEVA VENTILA...

K990177 is an FDA 510(k) clearance for NELLCOR PURITAN BENNETT ACHIEVA VENTILA..., manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K990177 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Nov 1999
Decision
303d
Days
Class 2
Risk

K990177 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K990177

510(k) Number K990177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 19, 1999
Decision Date November 18, 1999
Days to Decision 303 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
163d slower than avg
Panel avg: 140d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K990177.
ESPIRT
K001208 · Respironics, Inc. · May 2000
BIRD V.I.P. GOLD/STERLING
K993449 · Bird Products Corp. · Dec 1999
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
K993071 · Puritan Bennett Corp. · Nov 1999
MILLENNIUM INFANT VENTILATOR
K993167 · Sechrist Industries, Inc. · Nov 1999
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K992670 · Instrumentation Industries, Inc. · Sep 1999
BEAR CUB 750 PSV
K992788 · Bear Medical Systems, Inc. · Sep 1999