Cleared Traditional

K970029 - KEELER SPECTRA INDIRECT OPHTHALMOSCOPE

K970029 is an FDA 510(k) clearance for KEELER SPECTRA INDIRECT OPHTHALMOSCOPE, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K970029 · Keeler Instruments, Inc. · Ophthalmic device
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Apr 1997
Decision
89d
Days
Class 2
Risk

K970029 is an FDA 510(k) clearance for the KEELER SPECTRA INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 89 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 Keeler Instruments, Inc. devices

FDA 510(k) Submission Details - K970029

510(k) Number K970029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1997
Decision Date April 02, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K970029.
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