Cleared Traditional

K001646 - PURITAN-BENNETT 840 VENTILATOR SYSTEM W...

K001646 is an FDA 510(k) clearance for PURITAN-BENNETT 840 VENTILATOR SYSTEM W..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K001646 · Puritan Bennett Corp. · Anesthesiology device
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Oct 2000
Decision
143d
Days
Class 2
Risk

K001646 is an FDA 510(k) clearance for the PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on October 20, 2000 after a review of 143 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K001646

510(k) Number K001646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 30, 2000
Decision Date October 20, 2000
Days to Decision 143 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
3d slower than avg
Panel avg: 140d · This submission: 143d
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 K001646.
BIRD TBIRD VELA VENTILATOR
K020746 · Bird Products Corp. · Apr 2002
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · Siemens Elema AB · Dec 2001
BIRD TBIRD LEGACY VENTILATOR
K003770 · Bird Products Corp. · Dec 2000
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
K002686 · Nellcor Puritan Bennett, Inc. · Oct 2000
ESPIRT
K001208 · Respironics, Inc. · May 2000
BIRD V.I.P. GOLD/STERLING
K993449 · Bird Products Corp. · Dec 1999