Cleared Traditional

K081264 - STATSTRAP NEONATAL INCUBATOR SAFETY STRAP

K081264 is an FDA 510(k) clearance for STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, manufactured by Children'S Health First, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 284-day FDA review.

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

FDA 510(k) Submission Details - K081264

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.

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 34
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
PEDIATRIC LIMB HOLDER
K963466 · Deroyal Industries, Inc. · Feb 1997
RESTRICTIVE LIMB HOLDER
K963468 · Deroyal Industries, Inc. · Jan 1997
TUXEDO VEST RESTRAINT
K963474 · Deroyal Industries, Inc. · Jan 1997
DISPOSABLE LIMB HOLDER
K963476 · Deroyal Industries, Inc. · Jan 1997
ROLL BELTS
K963467 · Deroyal Industries, Inc. · Jan 1997