Cleared Traditional

K890825 - JUMPER PACK #203

K890825 is the FDA 510(k) clearance for JUMPER PACK #203 by O.R. Specialties, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K890825 · O.R. Specialties, Inc. · Ophthalmic device
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May 1989
Decision
98d
Days
Class 2
Risk

K890825 is an FDA 510(k) clearance for the JUMPER PACK #203. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on May 26, 1989 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 O.R. Specialties, Inc. devices

Submission Details

510(k) Number K890825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1989
Decision Date May 26, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 99
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