510(k) Report

FDA applicant

Organon Teknika Corp.

Durham, NC134 decisions1979–200015 recalls

FDA records 134 decisions for Organon Teknika Corp. (Durham, NC) from 1979 to 2000: 130 510(k) clearances and 4 original PMA approvals. Most are in product codes MDB (System, Blood Culturing) and FKT (System, Dialysate Delivery, Sorbent Regenerated). Its devices cite 9 predicates, 4 of them its own earlier devices. 15 recalls are linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Organon Teknika Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Organon Teknika Corp. since 2007.

Recalls per year

1in 2015

2007: 12012: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Organon Teknika Corp.’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?

  • MDBSystem, Blood Culturing19decisions
  • FKTSystem, Dialysate Delivery, Sorbent Regenerated9decisions
  • JTNSusceptibility Test Discs, Antimicrobial8decisions
  • FJIDialyzer, Capillary, Hollow Fiber7decisions
  • KOCAccessories, Blood Circuit, Hemodialysis5decisions
  • DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control5decisions

Also: GJS (5), JPA (5), LIB (4), JTC (3), GKP (3), KOI (3).

Whose devices does it build on?

Its devices cite 9 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 4 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.

  • K924453Multi-Channel Discrete Analyzer (Mda-180)Organon Teknika Corp. · 19923cite it
  • K903505Bact/Alert (TM)Organon Teknika Corp. · 19912cite it
  • K972698Tof-WatchOrganon Teknika Corp. · 19972cite it
  • K962857Coag-a-Mate MTXOrganon Teknika Corp. · 19972cite it
  • K992598Tof-Watch SXOrganon Teknika Corp. · 19992cite it
  • K993421Bact/Alert SNOrganon Teknika Corp. · 19991cites it

What has FDA decided for it lately?

  • K003104Bact/Alert CSROrganon Teknika Corp. · 2000
  • K000492Mda D-DimerOrganon Teknika Corp. · 2000
  • K000378Bact/Alert MB Culture BottleOrganon Teknika Corp. · 2000
  • K994343Bact/Alert SVOrganon Teknika Corp. · 2000
  • K993423Bact/Alert SAOrganon Teknika Corp. · 1999
  • K993421Bact/Alert SNOrganon Teknika Corp. · 19991 recall
  • K993576Bact/Alert MP Process BottleOrganon Teknika Corp. · 1999
  • K992432Bact/Alert FNOrganon Teknika Corp. · 19991 recall

All 134 as Organon Teknika Corp. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K993421BacT/ALERT SN, bioMrieux, Inc. Product Usage: BacT/ALERT Culture Bottles are used with…Dec 24, 2015Class II
  • K933939BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an…Mar 5, 2012
  • K992432BacT/ALERT FN Culture Bottles, Product Number 259793Feb 16, 2007
  • K903505BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system…Dec 19, 2006
  • K903505BacT/ALERT Classic System Software, Blood Culturing SystemAug 14, 2006
  • K934593BacT/ALERT 3D System Software, Blood Culturing SystemAug 14, 2006

Other applicant names beginning “Organon”

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

Organon, Inc. 42Organon Teknika Treyburn 1