Cleared Traditional

K093426 - BACT-TRAP HEPA MIDI

K093426 is an FDA 510(k) clearance for BACT-TRAP HEPA MIDI, manufactured by Pharma Systems AB. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K093426 · Pharma Systems AB · General Hospital
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Feb 2010
Decision
111d
Days
Class 2
Risk

K093426 is an FDA 510(k) clearance for the BACT-TRAP HEPA MIDI. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Pharma Systems AB (Bonita Springs, US). The FDA issued a Cleared decision on February 22, 2010 after a review of 111 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 Pharma Systems AB devices

FDA 510(k) Submission Details - K093426

510(k) Number K093426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2009
Decision Date February 22, 2010
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
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 116
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K093426.
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
K092409 · Intersurgical, Inc. · Mar 2010
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120 · Datex-Ohmeda, Inc. · Mar 2005
CLEAR-THERM MICRO HME, MODEL 1441
K032322 · Intersurgical, Inc. · May 2004