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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 196
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K093426.
INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
K092451 · Intersurgical, Inc. · Oct 2010
FIL 1520
K101629 · Glenn Medical Systems, Inc. · Jul 2010
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
K092409 · Intersurgical, Inc. · Mar 2010
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
K091363 · Ag Industries · Feb 2010
FLEXICARE BREATHING FILTERS
K092218 · Flexicare Medical, Ltd. · Oct 2009
THERMOFLO HCH, THERMOFLO FILTER
K090738 · Arc Medical, Inc. · Jul 2009
K093426 · BACT-TRAP HEPA MIDI
Download PDF FDA Summary Pharma Systems AB