Cleared Traditional

SINGLE BASIN SET (K844611) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844611 · Packaging Technologies, Inc. · General Hospital
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Dec 1984
Decision
22d
Days
Class 2
Risk

K844611 is an FDA 510(k) clearance for the SINGLE BASIN SET. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Packaging Technologies, Inc. (Brea, US). The FDA issued a Cleared decision on December 19, 1984 after a review of 22 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 Packaging Technologies, Inc. devices

Submission Details

510(k) Number K844611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date December 19, 1984
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 88
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K844611.
G.E. STERILE PUNCTURE TRAY
K960202 · GE Medical Systems · Feb 1996
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977