510(k) Report

FDA applicant

Nastech Pharmaceutical Company, Inc.

Hauppauge, NY2 decisions2001–20031 recall

FDA records 2 decisions for Nastech Pharmaceutical Company, Inc. (Hauppauge, NY) from 2001 to 2003: 2 510(k) clearances. All are in product code KNW (Instrument, Biopsy). 1 recall is linked to its devices, 1 Class I.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Nastech Pharmaceutical Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nastech Pharmaceutical Company, Inc. since 2007.

Recalls per year

1in 2013

2013: 1, 1 Class I
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nastech Pharmaceutical Company, 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?

  • KNWInstrument, Biopsy2decisions

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.

  • K012088Nastech Mammary Aspiration Speciman Cytology Test MasctNastech Pharmaceutical Company, Inc. · 20011cites it

What has FDA decided for it lately?

  • K030443Mammary Aspiration Specimen Cytology TestNastech Pharmaceutical Company, Inc. · 20031 Class I recall
  • K012088Nastech Mammary Aspiration Speciman Cytology Test MasctNastech Pharmaceutical Company, Inc. · 2001

All 2 as Nastech Pharmaceutical Company, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K030443Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test…Sep 19, 2013Class I