Cleared Traditional

MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) (K852334) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852334 · Design Med. Corp. · Ophthalmic device
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Jun 1985
Decision
18d
Days
Class 2
Risk

K852334 is an FDA 510(k) clearance for the MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN). Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Design Med. Corp. (Lake Forest, US). The FDA issued a Cleared decision on June 18, 1985 after a review of 18 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 Design Med. Corp. devices

Submission Details

510(k) Number K852334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date June 18, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 110d · This submission: 18d
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.