Cleared Traditional

K960515 - PARAPAC

K960515 is an FDA 510(k) clearance for PARAPAC, manufactured by Pneupac , Ltd.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K960515 · Pneupac , Ltd. · Anesthesiology device
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Oct 1996
Decision
248d
Days
Class 2
Risk

K960515 is an FDA 510(k) clearance for the PARAPAC. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Pneupac , Ltd. (Luton Beds Lu2 Oah, GB). The FDA issued a Cleared decision on October 10, 1996 after a review of 248 days - an extended review 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: 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 Pneupac , Ltd. devices

FDA 510(k) Submission Details - K960515

510(k) Number K960515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date October 10, 1996
Days to Decision 248 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 140d · This submission: 248d
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 47
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K960515.
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · Vortran Medical Technology 1, Inc. · Jul 2000
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · Instrumentation Industries, Inc. · Aug 1999
RESPIRTECHPRO
K973975 · Vortran Medical Technology 1, Inc. · Jun 1998
DRAGER MEDICAL AIR COMPRESSOR
K951126 · Drager, Inc. · Mar 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
K941870 · Life Support Products, Inc. · Jan 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
K941871 · Life Support Products, Inc. · Jan 1995