Cleared Traditional

K021265 - DATEX-OHMEDA HMEF 500

K021265 is an FDA 510(k) clearance for DATEX-OHMEDA HMEF 500, manufactured by Datex-Ohmeda. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K021265 · Datex-Ohmeda · General Hospital
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Aug 2002
Decision
130d
Days
Class 2
Risk

K021265 is an FDA 510(k) clearance for the DATEX-OHMEDA HMEF 500. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Ohmeda devices

FDA 510(k) Submission Details - K021265

510(k) Number K021265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2002
Decision Date August 30, 2002
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K021265.
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · Datex-Ohmeda · Jun 2003
DATEX-OHMEDA HMEF 750
K031653 · Datex-Ohmeda · Jun 2003
DATEX-OHMEDA HMEF MINI
K023641 · Datex-Ohmeda · Nov 2002
TERUMO GAS FILTER
K021020 · Terumo Cardiovascular Systems Corp. · Jun 2002
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001