Cleared Traditional

K925827 - IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINF...

K925827 is an FDA 510(k) clearance for IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINF..., manufactured by Impra, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K925827 · Impra, Inc. · Anesthesiology device
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Jul 1993
Decision
255d
Days
Class 2
Risk

K925827 is an FDA 510(k) clearance for the IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on July 29, 1993 after a review of 255 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - 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 Impra, Inc. devices

FDA 510(k) Submission Details - K925827

510(k) Number K925827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date July 29, 1993
Days to Decision 255 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
115d slower than avg
Panel avg: 140d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 - CAC Apparatus, Autotransfusion

All 141
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K925827.
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BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
K931106 · Deknatel, Inc. · Oct 1993
AUTOTRANSFUSION SUCTION SET
K920618 · Lifestream Int'L, Inc. · Mar 1993
AUTOVAC 7900 SERIES
K924894 · Boehringer Laboratories · Feb 1993
DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM
K914119 · Davol, Inc. · Dec 1992