FDA 510(k) clearance · back to tracker

ACCUJECT Injector Set 2.1-1P (LP604590)

Medicel AG cleared K252540 on 2025-09-16, decision: substantially equivalent

K-number

K252540

Sponsor

Medicel AG

Device

ACCUJECT Injector Set 2.1-1P (LP604590)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-09-16

Product code

MSS

Advisory committee

Ophthalmic

Medical specialty

Ophthalmic

Regulation number

886.4300

Official FDA record

Open K252540on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K252540 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.