Cleared Traditional

K993051 - VERSALET 7700 CARE CENTER, MODEL # 7700

K993051 is an FDA 510(k) clearance for VERSALET 7700 CARE CENTER, manufactured by Hill-Rom Air-Shields. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K993051 · Hill-Rom Air-Shields · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
143d
Days
Class 2
Risk

K993051 is an FDA 510(k) clearance for the VERSALET 7700 CARE CENTER, MODEL # 7700. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Hill-Rom Air-Shields (Hatboro, US). The FDA issued a Cleared decision on February 3, 2000 after a review of 143 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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 Hill-Rom Air-Shields devices

FDA 510(k) Submission Details - K993051

510(k) Number K993051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date February 03, 2000
Days to Decision 143 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
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMZ Device Classification - Class 2, Special Controls

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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 - FMZ Incubator, Neonatal

All 49
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K993051.
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