510(k) Report

FDA applicant

Sdi Diagnostics, Inc.

Easton, MA10 decisions1993–20160 recalls

FDA records 10 decisions for Sdi Diagnostics, Inc. (Easton, MA) from 1993 to 2016: 10 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 6 predicates, 2 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, anesthesiology panel, where it files most

How often FDA has decided Sdi Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 22010: 12016: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sdi Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BZGSpirometer, Diagnostic8decisions
  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • JAXPneumotachometer1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K934509Pulmoguard Disposable Baterial/Viral FilterSdi Diagnostics, Inc. · 19933cite it
  • K013812Spirolab II, Model 29Sdi Diagnostics, Inc. · 20022cite it
  • K031643Spirotel, Model 29-1020Sdi Diagnostics, Inc. · 20032cite it
  • K092813Astrasonic Spirometer, Model 29-8000Sdi Diagnostics, Inc. · 20101cites it

What has FDA decided for it lately?

  • K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc. · 2016
  • K092813Astrasonic Spirometer, Model 29-8000Sdi Diagnostics, Inc. · 2010
  • K061571ASTRA 300Sdi Diagnostics, Inc. · 2007
  • K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007
  • K033939Flosense II, Model 29-8040Sdi Diagnostics, Inc. · 2004
  • K031643Spirotel, Model 29-1020Sdi Diagnostics, Inc. · 2003
  • K013812Spirolab II, Model 29Sdi Diagnostics, Inc. · 2002
  • K011470Sdi SB Office, Model 29-Sdi Diagnostics, Inc. · 2001

All 10 as Sdi Diagnostics, Inc. →