Cleared Traditional

K964204 - ENGSTROM HMEF 1000

K964204 is an FDA 510(k) clearance for ENGSTROM HMEF 1000, manufactured by Datex Engstrom AB. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K964204 · Datex Engstrom AB · General Hospital
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Nov 1996
Decision
76d
Days
Class 2
Risk

K964204 is an FDA 510(k) clearance for the ENGSTROM HMEF 1000. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Datex Engstrom AB (Mccordsville, US). The FDA issued a Cleared decision on November 13, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 Datex Engstrom AB devices

FDA 510(k) Submission Details - K964204

510(k) Number K964204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1996
Decision Date November 13, 1996
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 141
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K964204.
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K964979 · Porous Media Corp. · Mar 1997
9000 SERIES FILTER & FILTER/HME
K963053 · Enternet Medical, Inc. · Feb 1997
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490 · Mercury Medical · Oct 1996
BACTERIA/VIRAL FILTER
K961914 · Hudson Respiratory Care, Inc. · Aug 1996