510(k) Report

510(k) · Cleared

Cleared

Ysi Model 23L Lactate Analyzer

K822812510(k) TraditionalCleared Dec 13, 198284-day reviewClass II21 CFR 884.4900

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

Yellow Springs Instrument Co., Inc. · HHP Table, Obstetrical, Manual (And Accessories)

Cleared on Dec 13, 1982 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 13, 1982
Review
84 days
Class
Class II
Product code
HHP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822812Source: 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 HHP? 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 HHP devices

HHP Table, Obstetrical, Manual (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHP

FDA has decided no HHP device since 2007.

Median 510(k) review, days · HHP

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

Recalls per year · HHP

No recall names HHP since 2007.

Adverse event reports per year · HHP

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2025

MAUDE reports naming product code HHP, 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—00
20100—02
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Yellow Springs Instrument Co., Inc.

23 FDA decisions under this applicant name. See the company

  • K962070Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 19962 recalls
  • K922821Ysi Models 4700 Foley Catheter Temperature ProbesYellow Springs Instrument Co., Inc. · 1992
  • K922007Ysi Model 441A Airway Temperature ProbeYellow Springs Instrument Co., Inc. · 1992
  • K910633Ysi Model 1500 Blood Glucose AnalyzerYellow Springs Instrument Co., Inc. · 1991
  • K910718Ysi Precision 4000 ThermometerYellow Springs Instrument Co., Inc. · 1991

Recent decisions in HHP

The HHP category page

  • K963505Tenet Mlti-Positioning Surgical Stirrup SystemTenet Medical Engineering · 1997

https://510kreport.com/device/K822812 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822812: Ysi Model 23L Lactate Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822812

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