Cleared Traditional

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (K081264) - FDA 510(k) Clearance

Class I General Hospital device.

K081264 · Children'S Health First, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
284d
Days
Class 1
Risk

K081264 is an FDA 510(k) clearance for the STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Children'S Health First, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 284 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Children'S Health First, Inc. devices

Submission Details

510(k) Number K081264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date February 13, 2009
Days to Decision 284 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
155d slower than avg
Panel avg: 129d · This submission: 284d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 133
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K081264.
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · Depuy, Inc. · Jul 1997
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
K963431 · Zimmer, Inc. · Nov 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393 · Depuy, Inc. · Oct 1996
RESTRAINT, PROTECTIVE
K780232 · Biomet, Inc. · Feb 1978