Cleared Traditional

K850119 - PHARMASEAL EYE PREP TRAY

K850119 is an FDA 510(k) clearance for PHARMASEAL EYE PREP TRAY, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K850119 · American Pharmaseal Div. Ahsc · Ophthalmic device
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May 1985
Decision
115d
Days
Class 1
Risk

K850119 is an FDA 510(k) clearance for the PHARMASEAL EYE PREP TRAY. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Glendale, US). The FDA issued a Cleared decision on May 9, 1985 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K850119

510(k) Number K850119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date May 09, 1985
Days to Decision 115 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 110d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

HNR Device Classification - Class 1, General Controls

Product Code HNR Forceps, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNR Forceps, Ophthalmic

All 29
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K850119.
STORZ/MAZZACCO LENS FORCEP
K860915 · Storz Instrument Co. · Apr 1986
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS
K851791 · Artiberia · May 1985
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS
K851792 · Artiberia · May 1985
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
K842697 · Downs Surgical , Ltd. · Aug 1984
MICRO FORCEPS
K834355 · Jedmed Instrument Co. · Mar 1984
MICROSURGICAL INSTRUMENTS
K823174 · Concept, Inc. · Nov 1982