Cleared Traditional

PEDIATRIC INGESTASCAN (K003305) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003305 · Adams Electronics, Inc. · Ophthalmic device
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Dec 2000
Decision
63d
Days
Class 2
Risk

K003305 is an FDA 510(k) clearance for the PEDIATRIC INGESTASCAN. Classified as Locator, Metal, Electronic (product code HPM), Class II - Special Controls.

Submitted by Adams Electronics, Inc. (Enid, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4400 - 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 Adams Electronics, Inc. devices

Submission Details

510(k) Number K003305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date December 22, 2000
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HPM Locator, Metal, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4400
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.