Cleared Traditional

K013200 - RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01

K013200 is an FDA 510(k) clearance for RENMED CONTAMI-SHIELD BREATHING CIRCUIT..., manufactured by Rennels Medical Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K013200 · Rennels Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
80d
Days
Class 2
Risk

K013200 is an FDA 510(k) clearance for the RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Rennels Medical Corp. (Morganton, US). The FDA issued a Cleared decision on December 14, 2001 after a review of 80 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 Rennels Medical Corp. devices

FDA 510(k) Submission Details - K013200

510(k) Number K013200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date December 14, 2001
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 132
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K013200.
TERUMO GAS FILTER
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EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · Engineered Medical Systems · Apr 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · Engineered Medical Systems · Mar 2002
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER
K012485 · King Systems Corp. · Oct 2001
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001