510(k) Report

510(k) · Cleared

Cleared

Branan Medical Corporation Monitect Barbiturates Drug Screen Test

K002337510(k) TraditionalCleared Nov 22, 2000113-day reviewClass II21 CFR 862.3150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Branan Medical Corporation · DIS Enzyme Immunoassay, Barbiturate

Cleared on Nov 22, 2000 after a 113-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 91 later devices descend from it.

Decided
Nov 22, 2000
Review
113 days
Class
Class II
Product code
DIS
Recalls
None
Predicates
0

91 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2004: 3 descendants cleared2003: 2 descendants cleared2006: 2 descendants cleared2013: 3 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2014: 4 descendants cleared2016: 9 descendants cleared2015: 9 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2018: 9 descendants cleared2020: 4 descendants cleared2023: 7 descendants cleared2019: 6 descendants cleared2017: 2 descendants cleared2025: 7 descendants cleared2021: 3 descendants cleared2024: 9 descendants cleared2022: 3 descendants cleared2026: 4 descendants cleared200020052010201520202025
  1. This deviceK002337 Branan Medical Corporation Monitect Barbiturates Drug Screen TestBranan Medical Corporation · 2000
  2. Descendant · cites it directly · 90 of its ownK012824 Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step…ACON Laboratories, Inc. · 2001
  3. Descendant · 2 generations on · 86 of its ownK023946 Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step…ACON Laboratories, Inc. · 2003
  4. Descendant · 3 generations on · 83 of its ownK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
  5. Descendant · 4 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
  6. Descendant · 5 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

2001: 12003: 22004: 32005: 12006: 22009: 12011: 12012: 12013: 32014: 42015: 92016: 92017: 22018: 92019: 62020: 42021: 32022: 32023: 72024: 92025: 72026: 4
2001high 9 (2015) · low 0 (2002)2026

Most influential descendants

Showing 5 of 91 · See all
  • K012824Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test DeviceACON Laboratories, Inc. · 2001 · cites it directly90descendants
  • K023946Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…ACON Laboratories, Inc. · 2003 · 2 generations on86descendants
  • K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc. · 2003 · 3 generations on83descendants
  • K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · 4 generations on80descendants
  • K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · 5 generations on55descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002337Branan Medical Corporation Monitect Barbiturates Drug Screen TestBranan Medical Corporation2000—
+1K012824Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test…ACON Laboratories, Inc.2001—
+2K023946Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…ACON Laboratories, Inc.2003—
+3K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum…ACON Laboratories, Inc.20031
+4K061718Innovacon Spectrum II Test CardInnovacon, Inc.20066
+5K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200320
200430
200510
200620
200910
201110
201210
201330
201440
201590
201690
201720
201890
201960
202040
202130
202230
202370
202490
202570
202640
FIG. 1 — Lineage of K002337, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (91)

See all 91

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012824Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test DeviceACON Laboratories, Inc.200190

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012824 (ACON Laboratories, Inc., 2001) has gone furthest, with 90 descendants of its own.

How does its category compare?

All DIS devices

DIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIS

1in 2016

2007: 32011: 22014: 22015: 32016: 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIS

29in 2015

2007: 331 days median2015: 29 days median
2007high 331 (2007) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DIS

1in 2016

2011: 12012: 12016: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DIS

1in 2018

2007: 12008: 12018: 1
2007high 1 (2007) · low 0 (2009)2025

MAUDE reports naming product code DIS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007333101
20080—01
20090—00
20100—00
20112—10
20120—10
20130—00
20142—00
201532900
20161—10
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Branan Medical Corporation

11 FDA decisions under this applicant name. See the company

  • 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
  • K002265Branan Medical Corporation Monitect Methamphetamine Drug Screen TestBranan Medical Corporation · 2000
  • K002268Branan Medical Corporation Monitect Morphine 2000 Drug Screen TestBranan Medical Corporation · 2000
  • K002264Branan Medical Corporation Monitect Cocaine Drug Screen TestBranan Medical Corporation · 2000

Recent decisions in DIS

The DIS category page

  • K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016
  • K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip…Assure Tech. Co., Ltd. · 2015
  • K150791Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette…Healgen Scientific,, LLC · 2015
  • K143535CR3 Keyless Split Sample Cup Secobarbital- MethadoneGuangzhou Wondfo Biotech Co., Ltd. · 2015
  • K140665GenPrime Snap-Top Split Key CupGenprime, Inc. · 2014

https://510kreport.com/device/K002337 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002337: Branan Medical Corporation Monitect Barbiturates Drug Screen Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002337

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026