Cleared Traditional

K800947 - MIDSTREAM COLLECTION KIT

K800947 is an FDA 510(k) clearance for MIDSTREAM COLLECTION KIT, 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 38-day FDA review.

K800947 · Sage Products, Inc. · General Hospital
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May 1980
Decision
38d
Days
Class 1
Risk

K800947 is an FDA 510(k) clearance for the MIDSTREAM COLLECTION KIT. 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 May 30, 1980 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 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 - K800947

510(k) Number K800947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1980
Decision Date May 30, 1980
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 K800947.
LANCER SPECIMEN CONTAINER
K812933 · Sherwood Medical Co. · Nov 1981
SPECIMEN SET
K802340 · American Pharmaseal Div. Ahsc · Oct 1980
URINE SPECIMEN CONTAINER #'S 1013-1016
K802002 · Pollak (Intl.), Ltd. · Sep 1980
ABCO MIDSTREAM URINE COLLECTION SET
K800233 · Abco Dealers, Inc. · Feb 1980
SPECIMEN COLLECTION PAN
K800309 · Sage Products, Inc. · Feb 1980
PARA-PAK CLEAN VIAL
K792710 · Meridian Diagnostics, Inc. · Jan 1980