510(k) Report

FDA applicant

Rodenstock Instrument Corp.

Boston, MA2 decisions1978–19890 recalls

FDA records 2 decisions for Rodenstock Instrument Corp. (Boston, MA) from 1978 to 1989: 2 510(k) clearances. Most are in product codes HLI (Ophthalmoscope, Ac-Powered) and HLM (Instrument, Measuring, Lens, Ac-Powered). 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 Rodenstock Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rodenstock Instrument Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rodenstock Instrument Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HLIOphthalmoscope, Ac-Powered1decision
  • HLMInstrument, Measuring, Lens, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K882517Rodenstock Scanning Laser OphthalmoscopeRodenstock Instrument Corp. · 19893cite it

What has FDA decided for it lately?

  • K882517Rodenstock Scanning Laser OphthalmoscopeRodenstock Instrument Corp. · 1989
  • K781440Lensometer Model 11Rodenstock Instrument Corp. · 1978

All 2 as Rodenstock Instrument Corp. →

Other applicant names beginning “Rodenstock”

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

Rodenstock USA Inc., 1