Cleared Traditional

K013093 - PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

K013093 is an FDA 510(k) clearance for PALL ULTIPOR ANESTHESIA BREATHING SYSTEM, manufactured by Pall Medical. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K013093 · Pall Medical · General Hospital
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Aug 2002
Decision
318d
Days
Class 2
Risk

K013093 is an FDA 510(k) clearance for the PALL ULTIPOR ANESTHESIA BREATHING SYSTEM. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Pall Medical (Ann Arbor, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pall Medical devices

FDA 510(k) Submission Details - K013093

510(k) Number K013093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date August 01, 2002
Days to Decision 318 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
189d slower than avg
Panel avg: 129d · This submission: 318d
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 125
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K013093.
DATEX-OHMEDA HMEF 750
K031653 · Datex-Ohmeda · Jun 2003
DATEX-OHMEDA HMEF MINI
K023641 · Datex-Ohmeda · Nov 2002
DATEX-OHMEDA HMEF 500
K021265 · Datex-Ohmeda · Aug 2002
TERUMO GAS FILTER
K021020 · Terumo Cardiovascular Systems Corp. · Jun 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · Engineered Medical Systems · Apr 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · Engineered Medical Systems · Mar 2002