510(k) Report

FDA applicant

Appasamy Associates

Arumbakkam, Chennai, IN2 decisions2008–20110 recalls

FDA records 2 decisions for Appasamy Associates (Arumbakkam, Chennai, IN) from 2008 to 2011: 2 510(k) clearances. Most are in product codes HLI (Ophthalmoscope, Ac-Powered) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Appasamy Associates’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12011: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Appasamy Associates by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Appasamy”

FDA records each applicant name separately; these may or may not be the same firm.