Cleared Traditional

K853891 - INDIRECT OPHTHALMOSCOPE

K853891 is the FDA 510(k) clearance for INDIRECT OPHTHALMOSCOPE by Carl Zeiss, Inc.. It is a Class 2 Ophthalmic device (product code HLJ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K853891 · Carl Zeiss, Inc. · Ophthalmic device
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Oct 1985
Decision
15d
Days
Class 2
Risk

K853891 is an FDA 510(k) clearance for the INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Carl Zeiss, Inc. devices

Submission Details

510(k) Number K853891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1985
Decision Date October 04, 1985
Days to Decision 15 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
95d faster than avg
Panel avg: 110d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HLJ Ophthalmoscope, Battery-powered

All 18
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K853891.
RI-FORMER
K932504 · Rudolf Riester GmbH & Co. KG · Oct 1993
OPHTHALMOSCOPE
K925757 · Rudolf Riester GmbH & Co. KG · Aug 1993
MIS
K923543 · Ceram Optec, Inc. · Mar 1993
MEDIC LUX DIAGNOSTIC SETS
K832437 · Keeler Instruments, Inc. · Aug 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215 · Jedmed Instrument Co. · Mar 1983
SOLA COMMIDO LOUPE
K760770 · Codman & Shurtleff, Inc. · Oct 1976