Cleared Traditional

K963437 - PELVIC HOLDERS

K963437 is an FDA 510(k) clearance for PELVIC HOLDERS, manufactured by J. T. Posey Co.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K963437 · J. T. Posey Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
81d
Days
Class 1
Risk

K963437 is an FDA 510(k) clearance for the PELVIC HOLDERS. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by J. T. Posey Co. (Arcadia, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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 J. T. Posey Co. devices

FDA 510(k) Submission Details - K963437

510(k) Number K963437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date November 19, 1996
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 121
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963437.
ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
K963563 · Tecnol Medical Products, Inc. · Nov 1996
24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
K963773 · Tecnol Medical Products, Inc. · Nov 1996
POSEY LAPTOP TRAYS
K963411 · J. T. Posey Co. · Nov 1996
PEDIATRIC LIMB HOLDERS
K963439 · J. T. Posey Co. · Nov 1996
CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
K963453 · Contour Fabricators, Inc. · Nov 1996
POSEY HUGGER
K963409 · J. T. Posey Co. · Nov 1996