Cleared Traditional

K921221 - STERILE/SINGLE USE SYMBLEPHARON RING

K921221 is an FDA 510(k) clearance for STERILE/SINGLE USE SYMBLEPHARON RING, manufactured by Storz Instrument Co.. The device is a Class 2 Ophthalmic device with product code HQN cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K921221 · Storz Instrument Co. · Ophthalmic device
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Jul 1992
Decision
126d
Days
Class 2
Risk

K921221 is an FDA 510(k) clearance for the STERILE/SINGLE USE SYMBLEPHARON RING. Classified as Conformer, Ophthalmic (product code HQN), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on July 17, 1992 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3130 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Storz Instrument Co. devices

FDA 510(k) Submission Details - K921221

510(k) Number K921221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date July 17, 1992
Days to Decision 126 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 110d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQN Device Classification - Class 2, Special Controls

Product Code HQN Conformer, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3130
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.