510(k) Report

FDA applicant

Branan Medical Corp.

Irvine, CA24 decisions2000–201315 recalls

FDA records 24 decisions for Branan Medical Corp. (Irvine, CA) from 2000 to 2013: 24 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and DJG (Enzyme Immunoassay, Opiates). Its devices cite 7 predicates, 0 of them its own earlier devices. 15 recalls are linked to its devices.

FDA’s records also spell it “Branan Medical Corporation”.

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

FIG. A — Illustration, clinical toxicology panel, where it files most

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

FDA decisions per year

2in 2013

2008: 12012: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

11in 2020

2014: 12017: 22019: 12020: 11
2007high 11 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Branan Medical 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?

  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites5decisions
  • DJGEnzyme Immunoassay, Opiates3decisions
  • DKZEnzyme Immunoassay, Amphetamine3decisions
  • LDJEnzyme Immunoassay, Cannabinoids3decisions
  • DJCThin Layer Chromatography, Methamphetamine2decisions
  • MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs1decision

Also: DJR (1), LCM (1), DOE (1), JXM (1), DIS (1), JXN (1).

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K004034Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12Branan Medical Corp. · 20012cite it
  • K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 20122cite it
  • K002337Branan Medical Corporation Monitect Barbiturates Drug Screen TestBranan Medical Corporation · 20001cites it

What has FDA decided for it lately?

  • K122633Toxcup Drug Screen CupBranan Medical Corp. · 20138 recalls
  • K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen DipcardBranan Medical Corp. · 2013
  • K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
  • K082508Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen DipcardBranan Medical Corporation · 20082 recalls
  • K040203Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen Dipstick Test, Model MF22Branan Medical Corp. · 2004
  • K032057Toxcup Drug Screen Cup Amp/Coc/Met/Opi/PCP/THCBranan Medical Corp. · 20032 recalls
  • K030113Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen Dipstick Test…Branan Medical Corp. · 20031 recall
  • K023489Quicktox Multiple Drug DipcardBranan Medical Corp. · 2002

All 13 as Branan Medical Corp. →All 11 as Branan Medical Corporation →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K122633CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA…Aug 18, 2020Class II
  • K122633First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700BAug 18, 2020Class II
  • K122633Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14…Aug 18, 2020Class II
  • K082508Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/…Aug 18, 2020Class II
  • K122633Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup"…Aug 18, 2020Class II
  • K122633Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx…Aug 18, 2020Class II