510(k) Report

FDA applicant

Remel Co.

Lenexa, KS164 decisions1979–201716 recalls

FDA records 164 decisions for Remel Co. (Lenexa, KS) from 1979 to 2017: 164 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and JTN (Susceptibility Test Discs, Antimicrobial). Its devices cite 8 predicates, 1 of them its own earlier devices. 16 recalls are linked to its devices.

FDA’s records also spell it “Remel, Inc.”, “Remel, L.P.”.

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 Remel Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12010: 12013: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 12009: 12010: 12011: 32018: 12021: 32023: 22024: 12025: 12026 (partial year): 1
2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JTODiscs, Strips And Reagents, Microorganism Differentiation49decisions
  • JTNSusceptibility Test Discs, Antimicrobial17decisions
  • JTSStains, Microbiologic12decisions
  • JSJCulture Media, Selective And Non-Differential11decisions
  • JSICulture Media, Selective And Differential9decisions
  • JSMCulture Media, Non-Propagating Transport6decisions

Also: JSO (6), LIO (5), JSF (4), JSN (2), MJD (2), LLH (2).

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 1 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.

  • K972359Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 19976cite it
  • K031565Xpect Influenza a/BRemel, Inc. · 20034cite it
  • K041951Xpect Clostridium Difficile Toxin a/BRemel, Inc. · 20043cite it
  • K850291Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 19853cite it
  • K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 20032cite it
  • K871447Todd Hewitt W/Cna (Lim Broth)Remel Co. · 19872cite it

What has FDA decided for it lately?

  • K162620Remel Spectra ESBLRemel, Inc. · 2017
  • K131804Remel Xpect Flu a&BRemel, Inc. · 2013
  • K092407Remel Spectra MrsaRemel, Inc. · 20101 recall
  • K072827Rpmi 1640 Agar W/Mops and 2% GlucoseRemel, Inc. · 2007
  • K041951Xpect Clostridium Difficile Toxin a/BRemel, Inc. · 2004
  • K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
  • K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003
  • K031965Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 20031 recall

All 137 as Remel Co. →All 17 as Remel, Inc. →All 10 as Remel, L.P. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K954986GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460Jun 3, 2026Class II
  • K843193Strep Selective II Agar, Product Number R01859Jul 11, 2025Class II
  • K920974remel BactiDrop Acridine Orange, REF 21502, 50 per package.Sep 20, 2024Class II
  • K871447remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci…Aug 14, 2023Class II
  • K892928Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus…May 31, 2023Class II
  • K972359Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package -…Apr 22, 2021Class II