Cleared Traditional

K963138 - SPIDER STRAP

K963138 is an FDA 510(k) clearance for SPIDER STRAP, manufactured by Bdm Medical, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K963138 · Bdm Medical, Inc. · General Hospital
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Nov 1996
Decision
85d
Days
Class 1
Risk

K963138 is an FDA 510(k) clearance for the SPIDER STRAP. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Bdm Medical, Inc. (Ashton, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 85 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 Bdm Medical, Inc. devices

FDA 510(k) Submission Details - K963138

510(k) Number K963138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1996
Decision Date November 06, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 K963138.
DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP
K963387 · Morrison Medical Products · Nov 1996
BEST STRAP RESTRAINT
K963371 · Morrison Medical Products · Nov 1996
HEELBO ER WRIST RESTRAINT
K963372 · Heelbo, Inc. · Nov 1996
MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS
K963399 · Morrison Medical Products · Nov 1996
ANKLE RESTRAINT SYSTEM
K963416 · Morrison Medical Products · Nov 1996
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
K963431 · Zimmer, Inc. · Nov 1996