Cleared Traditional

K854869 - INTRAOCULAR FORCEPS & SCISSORS

K854869 is an FDA 510(k) clearance for INTRAOCULAR FORCEPS & SCISSORS, manufactured by Mira, Inc.. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K854869 · Mira, Inc. · Ophthalmic device
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Mar 1986
Decision
91d
Days
Class 1
Risk

K854869 is an FDA 510(k) clearance for the INTRAOCULAR FORCEPS & SCISSORS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on March 5, 1986 after a review of 91 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 Mira, Inc. devices

FDA 510(k) Submission Details - K854869

510(k) Number K854869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1985
Decision Date March 05, 1986
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
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 31
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K854869.
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
K864003 · Allergan, Inc. · Oct 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861141 · CooperVision, Inc. · Apr 1986
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
PHARMASEAL EYE PREP TRAY
K850119 · American Pharmaseal Div. Ahsc · May 1985