Cleared Traditional

K792211 - SPECIMAN CUP & EMESIS BASIN

K792211 is an FDA 510(k) clearance for SPECIMAN CUP & EMESIS BASIN, manufactured by General Clinical Plastics Corp.. The device is a Class 1 General Hospital device with product code FMH cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K792211 · General Clinical Plastics Corp. · General Hospital
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Nov 1979
Decision
14d
Days
Class 1
Risk

K792211 is an FDA 510(k) clearance for the SPECIMAN CUP & EMESIS BASIN. Classified as Container, Specimen, Sterile (product code FMH), Class I - General Controls.

Submitted by General Clinical Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 14 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 General Clinical Plastics Corp. devices

FDA 510(k) Submission Details - K792211

510(k) Number K792211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1979
Decision Date November 16, 1979
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 15
Devices cleared under the same product code (FMH) and FDA review panel - the closest regulatory comparables to K792211.
SPECIMEN COLLECTION PAN
K800309 · Sage Products, Inc. · Feb 1980
PARA-PAK CLEAN VIAL
K792710 · Meridian Diagnostics, Inc. · Jan 1980
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
24-HOUR URINE COLLECTION COOLING WRAP
K781557 · Sage Products, Inc. · Oct 1978