Cleared Traditional

K951024 - NATURE'S CRADLE

K951024 is an FDA 510(k) clearance for NATURE'S CRADLE, manufactured by Infant Advantage, Inc.. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K951024 · Infant Advantage, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
91d
Days
Class 2
Risk

K951024 is an FDA 510(k) clearance for the NATURE'S CRADLE. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Infant Advantage, Inc. (Fremont, US). The FDA issued a Cleared decision on June 5, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5140 - 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.

FDA 510(k) Submission Details - K951024

510(k) Number K951024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date June 05, 1995
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMS Device Classification - Class 2, Special Controls

Product Code FMS Bed, Pediatric Open Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5140
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMS Bed, Pediatric Open Hospital

All 26
Devices cleared under the same product code (FMS) and FDA review panel - the closest regulatory comparables to K951024.
VAIL 100 PEDIATRIC CRIB
K963210 · Vail Products, Inc. · Nov 1996
NATURE'S CRADLE MODEL C1500
K960747 · Infant Advantage, Inc. · May 1996
STRYKER ADEL BASSINET
K960012 · Stryker Corp. · Mar 1996
BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B
K950051 · The Brewer Co. · Feb 1995
MC HEALTHCARE #CH31 CHILD'S CRIB
K950058 · Janco Consulting Services · Feb 1995
MC INFANT CARE UNIE #PP30
K950059 · Janco Consulting Services · Feb 1995
K951024 · NATURE'S CRADLE
Download PDF FDA Summary Infant Advantage, Inc.