Cleared Traditional

K842697 - ROOTMAN ORBITAL SURGERY INSTRUMENT SET

K842697 is an FDA 510(k) clearance for ROOTMAN ORBITAL SURGERY INSTRUMENT SET, manufactured by Downs Surgical , Ltd.. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K842697 · Downs Surgical , Ltd. · Ophthalmic device
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Aug 1984
Decision
27d
Days
Class 1
Risk

K842697 is an FDA 510(k) clearance for the ROOTMAN ORBITAL SURGERY INSTRUMENT SET. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Walker, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 27 days - a notably fast clearance cycle.

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: 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K842697

510(k) Number K842697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1984
Decision Date August 07, 1984
Days to Decision 27 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
83d faster than avg
Panel avg: 110d · This submission: 27d
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 K842697.
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
MICRO FORCEPS
K834355 · Jedmed Instrument Co. · Mar 1984
MICROSURGICAL INSTRUMENTS
K823174 · Concept, Inc. · Nov 1982
ANIS LENS IMPLANT FORCEPS #2
K811658 · American V. Mueller · Jun 1981