Cleared Traditional

K812600 - GER 540

K812600 is an FDA 510(k) clearance for GER 540, manufactured by G.W. Healthcare, Inc.. The device is a Class 1 General Hospital device with product code FNJ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K812600 · G.W. Healthcare, Inc. · General Hospital
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Sep 1981
Decision
9d
Days
Class 1
Risk

K812600 is an FDA 510(k) clearance for the GER 540, GER 541 MANUAL BED. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by G.W. Healthcare, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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 G.W. Healthcare, Inc. devices

FDA 510(k) Submission Details - K812600

510(k) Number K812600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1981
Decision Date September 23, 1981
Days to Decision 9 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
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

FNJ Device Classification - Class 1, General Controls

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
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 - FNJ Bed, Manual

All 8
Devices cleared under the same product code (FNJ) and FDA review panel - the closest regulatory comparables to K812600.
ICU/CPU TRANSPORT TRAY
K864878 · Orthopedic Systems, Inc. · Jan 1987
EGERTON TURNING & TILTING NET SUSPEN BED
K832845 · Kinetic Concepts, Inc. · Nov 1983
SIDE RAIL PADS
K823821 · Danek Medical, Inc. · Jan 1983
TELESCOPING BEDRAILS
K772260 · Med Fusion Systems, Inc. · Jan 1978
TRAPEZE FLOOR BASE
K772261 · Med Fusion Systems, Inc. · Jan 1978
TRAPEZE BAR KNOCKED DOWN
K772262 · Med Fusion Systems, Inc. · Jan 1978