510(k) Report

FDA applicant

Bradstreet Clinical Research Assoc., Inc.

Brunswick, NJ4 decisions1995–19981 recall

FDA records 4 decisions for Bradstreet Clinical Research Assoc., Inc. (Brunswick, NJ) from 1995 to 1998: 4 510(k) clearances. Most are in product codes LRX (Case, Contact Lens) and BYI (Percussor, Powered-Electric). Its devices cite 2 predicates, 1 of them its own earlier devices. 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, ophthalmic panel, where it files most

How often FDA has decided Bradstreet Clinical Research Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bradstreet Clinical Research Assoc., Inc. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bradstreet Clinical Research Assoc., Inc. 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?

  • LRXCase, Contact Lens2decisions
  • BYIPercussor, Powered-Electric2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K972859Flutter DBradstreet Clinical Research Assoc., Inc. · 19984cite it
  • K946083Flutter (R)Bradstreet Clinical Research Assoc., Inc. · 19953cite it

What has FDA decided for it lately?

  • K972859Flutter DBradstreet Clinical Research Assoc., Inc. · 1998
  • K951182Ryder Contact Lens Case Model 10670Bradstreet Clinical Research Assoc., Inc. · 1995
  • K951181Ryder Contact Lens CaseBradstreet Clinical Research Assoc., Inc. · 1995
  • K946083Flutter (R)Bradstreet Clinical Research Assoc., Inc. · 19951 recall

All 4 as Bradstreet Clinical Research Assoc., Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K946083FLUTTER Percussor respiratory device, packaged one unit per clear plastic package.…Nov 13, 2014Class II