Cleared Traditional

K000416 - TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

K000416 is an FDA 510(k) clearance for TRANSPAK (VITREORETINAL INFUSION PAK), manufactured by Retinalabs.Com. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000416 · Retinalabs.Com · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
90d
Days
Class 2
Risk

K000416 is an FDA 510(k) clearance for the TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on May 8, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 Retinalabs.Com devices

FDA 510(k) Submission Details - K000416

510(k) Number K000416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2000
Decision Date May 08, 2000
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - MPA Endoilluminator

All 32
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