Cleared Traditional

K880838 - BASSINET STAND WITH DRESSING TRAY

K880838 is an FDA 510(k) clearance for BASSINET STAND WITH DRESSING TRAY, manufactured by Serv-Queen, Inc.. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K880838 · Serv-Queen, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
59d
Days
Class 2
Risk

K880838 is an FDA 510(k) clearance for the BASSINET STAND WITH DRESSING TRAY. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Serv-Queen, Inc. (Daytona Beach, US). The FDA issued a Cleared decision on April 29, 1988 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 880.5140 - 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: 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 Serv-Queen, Inc. devices

FDA 510(k) Submission Details - K880838

510(k) Number K880838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date April 29, 1988
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
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. 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.