Cleared Traditional

PEDI-SPIDER STRAP (K061721) - FDA 510(k) Clearance

Class I General Hospital device.

K061721 · Emergency Products and Research · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
59d
Days
Class 1
Risk

K061721 is an FDA 510(k) clearance for the PEDI-SPIDER STRAP. Classified as Stretcher, Patient Restraint (product code NZD), Class I - General Controls.

Submitted by Emergency Products and Research (Kent, US). The FDA issued a Cleared decision on August 17, 2006 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - 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 Emergency Products and Research devices

Submission Details

510(k) Number K061721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2006
Decision Date August 17, 2006
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NZD Stretcher, Patient Restraint
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
Definition Soft Restraints To Be Attached To A Backboard Or Stretcher In Order To Immobilize The Patient In Emgency Situations.
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.