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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K974630.
TERUMO GAS FILTER
K021020 · Terumo Cardiovascular Systems Corp. · Jun 2002
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
PFT FILTER
K952062 · Intertech Resources, Inc. · Jun 1995