Cleared Traditional

K843955 - EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR

K843955 is an FDA 510(k) clearance for EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYG..., manufactured by Extracorporeal Medical Specialities, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K843955 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
51d
Days
Class 2
Risk

K843955 is an FDA 510(k) clearance for the EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight 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 Extracorporeal Medical Specialities, Inc. devices

FDA 510(k) Submission Details - K843955

510(k) Number K843955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1984
Decision Date November 29, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 220
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K843955.
AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH
K844901 · American Bentley · Mar 1985
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · Cobe Laboratories, Inc. · Feb 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · Scimed Life Systems, Inc. · Jan 1985
TUBULAR HOLLOW FIBER MEMBRANE
K841476 · American Bentley · Aug 1984
HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000
K833078 · Cordis Corp. · Jan 1984
BOS-CM40,50 HOLDER & RESERVOIR BAG
K833670 · American Bentley · Jan 1984