Cleared Traditional

K974630 - 72 HOUR USE TRACH CARE WITH MICROBAN

K974630 is an FDA 510(k) clearance for 72 HOUR USE TRACH CARE WITH MICROBAN, manufactured by Ballard Medical Products. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K974630 · Ballard Medical Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
89d
Days
Class 2
Risk

K974630 is an FDA 510(k) clearance for the 72 HOUR USE TRACH CARE WITH MICROBAN. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 89 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 Ballard Medical Products devices

FDA 510(k) Submission Details - K974630

510(k) Number K974630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1997
Decision Date March 11, 1998
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 156
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K974630.
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
K982127 · Porous Media Corp. · Jun 1998
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · King Systems Corp. · Mar 1998
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
K973238 · Bill Olson Corp. · Mar 1998
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K965016 · Gibeck, Inc. · Dec 1997
SPIROSAFE FILTER
K973314 · Micro Direct, Inc. · Nov 1997
FILTER
K970102 · Promedic, Inc. · Jun 1997