Cleared Traditional

K051322 - PNEUPAC VRI STANDARD

K051322 is an FDA 510(k) clearance for PNEUPAC VRI STANDARD, manufactured by Smiths Medical International , Ltd.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K051322 · Smiths Medical International , Ltd. · Anesthesiology device
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Aug 2005
Decision
77d
Days
Class 2
Risk

K051322 is an FDA 510(k) clearance for the PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Smiths Medical International , Ltd. (Waukesha, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Smiths Medical International , Ltd. devices

FDA 510(k) Submission Details - K051322

510(k) Number K051322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2005
Decision Date August 05, 2005
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K051322.
AUTOVENT MODEL 4000
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GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210 · Ohmeda Medical · Apr 2007
UNI-VENT MODEL 73X
K051476 · Impact Instrumentation, Inc. · Oct 2005
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K041473 · Vortran Medical Technology 1, Inc. · Jul 2004
COMPPAC 200HD
K040090 · Pneupac , Ltd. · May 2004
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K032386 · Impact Instrumentation, Inc. · Mar 2004