Cleared Traditional

K864846 - RADIOGRAPHIC - LEG SECTION

K864846 is an FDA 510(k) clearance for RADIOGRAPHIC - LEG SECTION, manufactured by American Sterilizer Co.. The device is a Class 1 Gastroenterology & Urology device with product code KQS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K864846 · American Sterilizer Co. · Gastroenterology & Urology device
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Dec 1986
Decision
14d
Days
Class 1
Risk

K864846 is an FDA 510(k) clearance for the RADIOGRAPHIC - LEG SECTION. Classified as Table, Cystometric, Non-electric And Accessories (product code KQS), Class I - General Controls.

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on December 24, 1986 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4890 - the FDA gastroenterology and urology 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 American Sterilizer Co. devices

FDA 510(k) Submission Details - K864846

510(k) Number K864846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1986
Decision Date December 24, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

KQS Device Classification - Class 1, General Controls

Product Code KQS Table, Cystometric, Non-electric And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4890
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 - KQS Table, Cystometric, Non-electric And Accessories

Devices cleared under the same product code (KQS) and FDA review panel - the closest regulatory comparables to K864846.
UROTRACT I
K955019 · Dornier Medtech America, Inc. · Dec 1995
HYDRAJUST III UROLOGICAL TABLE
K860040 · Mallinckrodt Group, Inc. · Feb 1986
AMSCO URO-ENDO MOBILE TABLE
K852127 · American Sterilizer Co. · Aug 1985
UR 150-UR 150T
K801723 · Siemens Corp. · Aug 1980
HYDRADJUST II UROLOGICAL TABLE
K791699 · Sybron Corp. · Oct 1979
TABLE, UROSURGICAL
K760522 · Mallinckrodt Group, Inc. · Dec 1976