Cleared Traditional

K811247 - CATHETER MAINTENANCE KIT

K811247 is an FDA 510(k) clearance for CATHETER MAINTENANCE KIT, manufactured by Clinipad Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K811247 · Clinipad Corp. · General Hospital
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Jun 1981
Decision
38d
Days
Class 2
Risk

K811247 is an FDA 510(k) clearance for the CATHETER MAINTENANCE KIT. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Clinipad Corp. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Clinipad Corp. devices

FDA 510(k) Submission Details - K811247

510(k) Number K811247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1981
Decision Date June 12, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 186
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K811247.
SURGIPEEL SELF-SEAL PACKAGING SYSTEM
K820302 · Surgicot, Inc. · Feb 1982
BOUNDARY STERILIZATION WRAP
K811819 · The Buckeye Cellulose Corp. · Aug 1981
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
DISPOSABLE STERILIZATION WRAP
K811242 · Amsco Co. · May 1981
OR/CS WRAP
K810646 · American Threshold Industries, Inc. · Mar 1981
ALOFT STERILIZATION WRAP
K803306 · American Hospital Supply Corp. · Feb 1981