510(k) Report

510(k) · Cleared

Cleared

Sensititre Auto ID Plate AP80

K890057510(k) TraditionalCleared Jun 9, 1989154-day reviewClass I21 CFR 866.2660

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

Radiometer America, Inc. · LQM Gram Negative Identification Panel

Cleared on Jun 9, 1989 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 9, 1989
Review
154 days
Class
Class I
Product code
LQM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890057Source: FDA 510(k) database · 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 LQM? 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LQM devices

LQM Gram Negative Identification Panel: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQM

FDA has decided no LQM device since 2007.

Median 510(k) review, days · LQM

Too few LQM 510(k)s in any year since 2007 to give a median.

Recalls per year · LQM

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LQM

17in 2025

2009: 12010: 12011: 12015: 692016: 12017: 772018: 882019: 122021: 32022: 72023: 302024: 342025: 17
2007high 88 (2018) · low 0 (2007)2025

MAUDE reports naming product code LQM, 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
20070—00
20080—00
20090—01
20100—01
20110—01
20120—00
20130—00
20140—00
20150—069
20160—01
20170—077
20180—088
20190—012
20200—00
20210—03
20220—17
20230—030
20240—034
20250—017
20260—0—

More from Radiometer America, Inc.

54 FDA decisions under this applicant name. See the company

  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 20004 recalls
  • K991417Abl 735 AnalyzerRadiometer America, Inc. · 19992 recalls
  • K982928NPT7 Series PH/Blood Gas and CO-Oximetry SystemRadiometer America, Inc. · 19992 recalls
  • K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 19985 recalls

Recent decisions in LQM

The LQM category page

  • K923313Roche Oxi/Ferm IIRoche Diagnostic Systems, Inc. · 1993
  • K925915Vitek Rapid Call-Gram Negativ Ident CardBiomerieux Vitek, Inc. · 1993
  • K912897Sceptor Identification SystemBd Becton Dickinson Vacutainer Systems Preanalytic · 1991
  • K911429Vitek Gram Negative Identification Card, ModifiedVitek Systems, Inc. · 1991
  • K862642Gram Negative Fluorescent Identification PanelAmerican Micro Scan · 1986

https://510kreport.com/device/K890057 · printed Nov 5, 2026

Cite this page

510(k) Report. “K890057: Sensititre Auto ID Plate AP80.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890057

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