Cleared Traditional

K840027 - OPERATING ROOM STAND

K840027 is an FDA 510(k) clearance for OPERATING ROOM STAND, manufactured by Healthmate, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSE cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K840027 · Healthmate, Inc. · General & Plastic Surgery device
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Feb 1984
Decision
30d
Days
Class 1
Risk

K840027 is an FDA 510(k) clearance for the OPERATING ROOM STAND. Classified as Table, Operating-room, Manual (product code FSE), Class I - General Controls.

Submitted by Healthmate, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K840027

510(k) Number K840027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date February 04, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

FSE Device Classification - Class 1, General Controls

Product Code FSE Table, Operating-room, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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 - FSE Table, Operating-room, Manual

All 10
Devices cleared under the same product code (FSE) and FDA review panel - the closest regulatory comparables to K840027.
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CHEMONUCLEOLYSIS TABLE EXTENSION
K831042 · Orthopedic Systems, Inc. · May 1983
SELF-CONTAINED MOBILE OPHTHAL. OPER. .
K822427 · Surgi-Quip Inc.U · Sep 1982
TABLE, OPERATING, FIELD 6530-00-709-8155
K821924 · Emerson-Sack-Warner Corp. · Jul 1982
ARMBOARD CVER, DISPOSABLE
K782092 · Anago, Inc. · Jan 1979
K840027 · OPERATING ROOM STAND
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