Cleared Traditional

K781557 - 24-HOUR URINE COLLECTION COOLING WRAP

K781557 is an FDA 510(k) clearance for 24-HOUR URINE COLLECTION COOLING WRAP, manufactured by Sage Products, Inc.. The device is a Class 1 General Hospital device with product code FMH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K781557 · Sage Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
36d
Days
Class 1
Risk

K781557 is an FDA 510(k) clearance for the 24-HOUR URINE COLLECTION COOLING WRAP. Classified as Container, Specimen, Sterile (product code FMH), Class I - General Controls.

Submitted by Sage Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 864.3250 - 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 Sage Products, Inc. devices

FDA 510(k) Submission Details - K781557

510(k) Number K781557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1978
Decision Date October 17, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

FMH Device Classification - Class 1, General Controls

Product Code FMH Container, Specimen, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMH Container, Specimen, Sterile

All 14
Devices cleared under the same product code (FMH) and FDA review panel - the closest regulatory comparables to K781557.
LANCER SPECIMEN CONTAINER
K792156 · Sherwood Medical Co. · Dec 1979
JUHN TYM-TAP
K790915 · Xomed, Inc. · Jun 1979
OPERATING ROOM SPECIMEN CONTAINER
K790291 · Sage Products, Inc. · Apr 1979
URINE SAMPLE COLLECTION KIT
K780057 · C.R. Bard, Inc. · Feb 1978
CATH KIT, URINE SPECIMEN
K780167 · C.R. Bard, Inc. · Feb 1978
SPECIMEN COLLECTOR
K770112 · Portex, Inc. · Mar 1977