510(k) Report

FDA applicant

Obp Corporation

Lawerence, MA2 decisions2009–20121 recall

FDA records 2 decisions for Obp Corporation (Lawerence, MA) from 2009 to 2012: 2 510(k) clearances. Most are in product codes HIB (Speculum, Vaginal, Nonmetal) and FER (Anoscope And Accessories). 1 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2012

2009: 12012: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2009high 1 (2026) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Obp Corporation by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HIBSpeculum, Vaginal, Nonmetal1decision
  • FERAnoscope And Accessories1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K091937Office-Spec Disposable Side-Opening SpeculumObp Corporation · 20091cites it

What has FDA decided for it lately?

  • K121604Anospec Disposable Ansoscope with LightObp Corporation · 2012
  • K091937Office-Spec Disposable Side-Opening SpeculumObp Corporation · 20091 recall

All 2 as Obp Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091937OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF…Jul 13, 2026Class II