Cleared Traditional

K971465 - NATIONAL MEDICAL HALTHCARE CUSTOM OPHTH...

K971465 is an FDA 510(k) clearance for NATIONAL MEDICAL HALTHCARE CUSTOM OPHTH..., manufactured by National Healthcare Mfg. Corp.. The device is a Class 1 General Hospital device with product code HOY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K971465 · National Healthcare Mfg. Corp. · General Hospital
Download Printable Device Report (PDF)
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Jun 1997
Decision
43d
Days
Class 1
Risk

K971465 is an FDA 510(k) clearance for the NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS. Classified as Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (product code HOY), Class I - General Controls.

Submitted by National Healthcare Mfg. Corp. (Great Neck, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 886.4750 - the FDA general hospital 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 National Healthcare Mfg. Corp. devices

FDA 510(k) Submission Details - K971465

510(k) Number K971465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1997
Decision Date June 04, 1997
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

HOY Device Classification - Class 1, General Controls

Product Code HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4750
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 - HOY Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

All 10
Devices cleared under the same product code (HOY) and FDA review panel - the closest regulatory comparables to K971465.
SHAIDS PROTECTIVE GLASSES
K930347 · Depuy, Inc. · Apr 1994
EYE BUBBLE
K912367 · Aaron Medical Industries · Oct 1991
UNIDIRECTIONAL OCCLUDER
K913230 · Welch Allyn, Inc. · Oct 1991
SOFT CORNEAL LIGHT SHIELD
K896681 · Visitec Co. · Jan 1990
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc. · Mar 1988
EYE GARD
K872000 · Treace Medical, Inc. · Jul 1987