Cleared Traditional

K022836 - STEPHENS DISPOSABLE SPECULUM

K022836 is an FDA 510(k) clearance for STEPHENS DISPOSABLE SPECULUM, manufactured by Stephens Instruments. The device is a Class 1 Ophthalmic device with product code HNC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K022836 · Stephens Instruments · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
66d
Days
Class 1
Risk

K022836 is an FDA 510(k) clearance for the STEPHENS DISPOSABLE SPECULUM. Classified as Specula, Ophthalmic (product code HNC), Class I - General Controls.

Submitted by Stephens Instruments (Lexington, US). The FDA issued a Cleared decision on November 1, 2002 after a review of 66 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 Stephens Instruments devices

FDA 510(k) Submission Details - K022836

510(k) Number K022836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2002
Decision Date November 01, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 110d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

HNC Device Classification - Class 1, General Controls

Product Code HNC Specula, 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 - HNC Specula, Ophthalmic

All 8
Devices cleared under the same product code (HNC) and FDA review panel - the closest regulatory comparables to K022836.
OCULOSTAT
K981235 · Laser Center Dev. Corp. · Jul 1998
EYE FIXATION SPECULUM
K964289 · Eyefix, Inc. · Dec 1996
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
K863989 · Keeler Instruments, Inc. · Oct 1986
VISITEC EYE SPECULUM
K843196 · Visitec Co. · Oct 1984
ASNIS GUIDED SCREW SYSTEMS
K801969 · Howmedica Corp. · Aug 1980
FELDSTEIN BLEPHAROPLASTY CLIP SHARP P
K760847 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976