Cleared Traditional

K854940 - TIPS AND PADS

K854940 is an FDA 510(k) clearance for TIPS AND PADS, manufactured by Healthtech Industries, Inc.. The device is a Class 1 General Hospital device with product code FNJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K854940 · Healthtech Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
51d
Days
Class 1
Risk

K854940 is an FDA 510(k) clearance for the TIPS AND PADS, CANE,CRUTCH AND WALKER. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Healthtech Industries, Inc. (Farmers Branch, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 51 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 Healthtech Industries, Inc. devices

FDA 510(k) Submission Details - K854940

510(k) Number K854940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1985
Decision Date January 30, 1986
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 K854940.
CRADLE, HOSPITAL BED CLOTHING
K892877 · Warsaw Orthopedic, Inc. · Jun 1989
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