510(k) Report

510(k) · Cleared

Cleared

Sodium & Potassium Test Kit

K810253510(k) TraditionalCleared Feb 10, 198111-day reviewClass II21 CFR 862.1600

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

Mallinckrodt Critical Care · JGM Flame Photometry, Potassium

Cleared on Feb 10, 1981 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 10, 1981
Review
11 days
Class
Class II
Product code
JGM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K810253Source: 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.

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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 JGM devices

JGM Flame Photometry, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGM

FDA has decided no JGM device since 2007.

Median 510(k) review, days · JGM

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

Recalls per year · JGM

No recall names JGM since 2007.

Adverse event reports per year · JGM

No MAUDE report names JGM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
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 Mallinckrodt Critical Care

92 FDA decisions under this applicant name. See the company

  • K880343Burney Gallbladder Catheter KitMallinckrodt Critical Care · 1989
  • K874605HI-LO Temp (R) Myocardial Temperature SensorMallinckrodt Critical Care · 1988
  • K874514HI-LO Temp (R) General Purpose Temperature ProbeMallinckrodt Critical Care · 1988
  • K874568HI-LO Temp (R) Model 8700 Patient Temp MonitorMallinckrodt Critical Care · 1988
  • K873461Laser-Flex (TM) Tracheal Tube (Cuffed)Mallinckrodt Critical Care · 1987

Recent decisions in JGM

The JGM category page

  • K895718Lithium Concentrate for a Flame PhotometerData Medical Associates, Inc. · 1989
  • K862300Amresco Flow Pac Sodium Potassium ReagentAmresco, Inc. · 1986
  • K831300Msi-Nak-50 Test KitMedical Specialties, Inc. · 1983
  • K771068Triglyceride KitEnvironmental Chemical Specialties · 1977

https://510kreport.com/device/K810253 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810253: Sodium & Potassium Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810253

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