Cleared Traditional

K930791 - AMERICAN POWER CONVERSIONS, BACK-UPS 600

K930791 is an FDA 510(k) clearance for AMERICAN POWER CONVERSIONS, manufactured by Bio Clinic Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K930791 · Bio Clinic Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
171d
Days
Class 2
Risk

K930791 is an FDA 510(k) clearance for the AMERICAN POWER CONVERSIONS, BACK-UPS 600. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Bio Clinic Co. (Ontario, US). The FDA issued a Cleared decision on August 6, 1993 after a review of 171 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Bio Clinic Co. devices

FDA 510(k) Submission Details - K930791

510(k) Number K930791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date August 06, 1993
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 512
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K930791.
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K930847 · Sherwood Medical Co. · Jul 1993