Cleared Traditional

K951514 - SSC MODEL 4000 SERIES

K951514 is an FDA 510(k) clearance for SSC MODEL 4000 SERIES, manufactured by Ssc Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K951514 · Ssc Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
338d
Days
Class 2
Risk

K951514 is an FDA 510(k) clearance for the SSC MODEL 4000 SERIES. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Ssc Medical Products, Inc. (Tupelo, US). The FDA issued a Cleared decision on March 6, 1996 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - 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. Elevated predicate reliance profile. 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 Ssc Medical Products, Inc. devices

FDA 510(k) Submission Details - K951514

510(k) Number K951514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date March 06, 1996
Days to Decision 338 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 129d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 - FNL Bed, Ac-powered Adjustable Hospital

All 27
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K951514.
ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
K964515 · M.C. Healthcare Products, Inc. · Dec 1996
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
K962250 · Carroll Healthcare, Inc. · Oct 1996
2000 MODULAR THIRTY-NINE
K962763 · Equi-Tron Mfg., Inc. · Oct 1996
BARIKARE PLUS
K945664 · Kinetic Concepts, Inc. · Feb 1995
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
K932663 · Medline Industries, Inc. · Nov 1993
GLENN BED
K931581 · Kinetic Concepts, Inc. · Oct 1993