510(k) Report

510(k) · Cleared

Recalled · 2011

Remel Spectra Mrsa

K092407510(k) TraditionalCleared Oct 8, 2010428-day reviewClass II21 CFR 866.1700Recalls 1

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

Remel, Inc. · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Cleared on Oct 8, 2010 after a 428-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Oct 8, 2010
Review
428 days
Class
Class II
Product code
JSO
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2010201520202025
  1. This deviceK092407 Remel Spectra MrsaRemel, Inc. · 2010
  2. Descendant · cites it directly · 0 of its ownK162076 chromID MRSAbioMerieux, Inc. · 2016 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K162076chromID MRSAbioMerieux, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092407Remel Spectra MrsaRemel, Inc.2010—
+1K162076chromID MRSAbioMerieux, Inc.20162

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K092407, 2010–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 JSO? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K162076chromID MRSAbioMerieux, Inc.20160

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

Recalls of this device

DateClassRecallRoot causeReason
May 11, 2011Not classifiedZ-2677-2011Process controlThe product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K162076 (bioMerieux, Inc., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JSO devices

JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · JSO

1in 2019

2007: 12008: 22009: 12010: 52011: 22012: 12016: 32017: 22018: 12019: 1
2007high 5 (2010) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JSO

262in 2016

2010: 326 days median2016: 262 days median
2007high 326 (2010) · low 262 (2016)2026

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

Recalls per year · JSO

15in 2022

2007: 22009: 42011: 32017: 22020: 12022: 15
2007high 15 (2022) · low 0 (2008)2026

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

Adverse event reports per year · JSO

513in 2025

2008: 12010: 12011: 12013: 12015: 322016: 172017: 432018: 142019: 92020: 72021: 272022: 82023: 122024: 42025: 513
2007high 513 (2025) · low 0 (2007)2025

MAUDE reports naming product code JSO, 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
20071—20
20082—01
20091—40
2010532601
20112—31
20121—00
20130—01
20140—00
20150—032
20163262017
20172—243
20181—014
20191—09
20200—17
20210—027
20220—158
20230—012
20240—04
20250—0513
20260—0—

More from Remel, Inc.

17 FDA decisions under this applicant name. See the company

  • K162620Remel Spectra ESBLRemel, Inc. · 2017
  • K131804Remel Xpect Flu a&BRemel, Inc. · 2013
  • 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

Recent decisions in JSO

The JSO category page

  • K190553HardyCHROM CREHardy Diagnostics · 20191 recall
  • K181092CHROMID CARBA agar (CARB)Biomerieux S.A. · 20181 recall
  • K171061MRSASelect IIBio-Rad · 20171 recall
  • K162620Remel Spectra ESBLRemel, Inc. · 2017
  • K160512HardyCHROM ESBLHardy Diagnostics · 2016

https://510kreport.com/device/K092407 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092407: Remel Spectra Mrsa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092407

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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