Cleared Traditional

K842542 - AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY

K842542 is an FDA 510(k) clearance for AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K842542 · American Pharmaseal Div. Ahsc · General Hospital
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Aug 1984
Decision
49d
Days
Class 2
Risk

K842542 is an FDA 510(k) clearance for the AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on August 20, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K842542

510(k) Number K842542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date August 20, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K842542.
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MONOJECT MENGHINI SOFT TISSUE BIOPSY
K843264 · Sherwood Medical Co. · Dec 1984
THINWALL PUNCTURE NEEDLE
K841704 · Meadox Surgimed, Inc. · Jun 1984
OHIO HEAT REFLECTING PATCH
K840967 · Ohio Medical Products · Mar 1984
INTRADISCAL THERAPY TRAY
K834553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1984