510(k) Report

FDA product code · Microbiology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

LONClass II21 CFR 866.1645510(k) required303 decisions since 1969172 recalls

303 FDA decisions since 1969. 510(k) reviews decided 2021–2025 took a median of 150 days (half between 90 and 292). 172 recalls name this code, 2 of them Class I. The most-cited predicate is K020321, named by 103 later devices.

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

FIG. A — Illustration, microbiology panel

Twenty years of LON at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · LON

5in 2025

2007: 192008: 72009: 82010: 12011: 82012: 102013: 72014: 42016: 32017: 102018: 42019: 82020: 52021: 52022: 82023: 112024: 22025: 52026 (partial year): 4
2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007: 50 days median2008: 66 days median2009: 76 days median2011: 85 days median2012: 200 days median2013: 115 days median2014: 90 days median2016: 242 days median2017: 89 days median2018: 88 days median2019: 84 days median2020: 81 days median2021: 268 days median2022: 189 days median2023: 210 days median2025: 90 days median2026 (partial year): 146 days median
2007high 268 (2021) · low 50 (2007)2026

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

Recalls per year · LON

1in 2025

2008: 12010: 1162011: 32012: 32014: 2, 2 Class I2016: 22017: 12018: 62019: 12020: 82022: 152024: 12025: 12026 (partial year): 6
2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007: 32008: 12010: 32011: 42012: 92013: 32014: 102015: 412016: 942017: 1972018: 5122019: 3152020: 2182021: 2322022: 1802023: 4532024: 4182025: 690
2007high 690 (2025) · low 0 (2009)2025

MAUDE reports naming product code LON, 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
2007195003
200876611
200987600
20101—1163
201188534
20121020039
2013711503
20144902 (2)10
20150—041
20163242294
201710891197
20184886512
20198841315
20205818218
202152680232
2022818915180
2023112100453
20242—1418
20255901690
202641466—
FIG. 1 — LON by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LON? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do LON devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K020321BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002103cite it
  • K020322BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 200294cite it
  • K020323BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 200291cite it
  • K063597Vitek 2 Gram Positive Amoxicillin for Streptococcus PneumoniaebioMerieux, Inc. · 200712cite it
  • K060324BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML -…Becton, Dickinson & CO · 200610cite it
  • K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 20127cite it

Which LON devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc. · 202111generations
  • K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc. · 202010generations
  • K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc. · 20199generations
  • K232756ColibríCopan Wasp Srl · 20238generations
  • K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL)…bioMerieux, Inc. · 20238generations
  • K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mLbioMerieux, Inc. · 20178generations

What has FDA decided in LON lately?

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025
  • K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company · 2025

All 303 LON decisions →

What has been recalled in LON lately?

  • K181665BD Phoenix Panel NMIC-306. Catalog Number: 449292.Becton Dickinson & Co. · Aug 13, 2026Class II
  • K181665BD Phoenix Panel NMIC-312. Catalog Number: 449082.Becton Dickinson & Co. · Aug 13, 2026Class II
  • Z-3231-2026VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference…Biomerieux Inc · Jul 24, 2026Class II
  • K201405REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…Beckman Coulter Inc. · Jun 26, 2026Class II
  • K201405REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the…Beckman Coulter Inc. · Jun 26, 2026Class II
  • Z-2715-2026VITEK 2 AST-N447 TEST KIT Product reference 424620Biomerieux Inc · Jun 4, 2026Class II