Cleared Traditional

K930043 - ACU-EVAC

K930043 is an FDA 510(k) clearance for ACU-EVAC, manufactured by Acuderm, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K930043 · Acuderm, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
400d
Days
Class 2
Risk

K930043 is an FDA 510(k) clearance for the ACU-EVAC. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Acuderm, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - 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 Acuderm, Inc. devices

FDA 510(k) Submission Details - K930043

510(k) Number K930043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date February 09, 1994
Days to Decision 400 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 129d · This submission: 400d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 - FYD Apparatus, Exhaust, Surgical

All 49
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K930043.
BUFFALO FILTER REPLACEMENT FILTER #BSPF030
K943226 · Buffalo Filter Co., Inc. · Jul 1995
BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
K943227 · Buffalo Filter Co., Inc. · Jul 1995
CRYSTAL VISION AND ACCESSORIES
K932230 · I.C Medical, Inc. · Feb 1994
BUFFALO FILTER REPLACEMENT FILTER #BPTU100
K930058 · Buffalo Filter Co., Inc. · Nov 1993
BUFFALO FILTER REPLACEMENT FILTER #BST300UL
K930062 · Buffalo Filter Co., Inc. · Nov 1993
BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO
K930060 · Buffalo Filter Co., Inc. · Nov 1993