Cleared Traditional

K924272 - MEDIRESP III

K924272 is an FDA 510(k) clearance for MEDIRESP III, manufactured by Medflow Corp., Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 534-day FDA review.

K924272 · Medflow Corp., Inc. · Anesthesiology device
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Feb 1994
Decision
534d
Days
Class 2
Risk

K924272 is an FDA 510(k) clearance for the MEDIRESP III. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Medflow Corp., Inc. (Hilton, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 534 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Medflow Corp., Inc. devices

FDA 510(k) Submission Details - K924272

510(k) Number K924272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date February 09, 1994
Days to Decision 534 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
394d slower than avg
Panel avg: 140d · This submission: 534d
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 79
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K924272.
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
IMPACT MODEL 753
K931473 · Impact Instrumentation, Inc. · Dec 1994
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
K932199 · Life Support Products, Inc. · Nov 1993
LSPI AUTOMATIC VENTILATOR
K932200 · Life Support Products, Inc. · Nov 1993
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910 · J. H. Emerson Co. · Jan 1993