510(k) Report

510(k) · Cleared

Cleared

Knai Sodium Potassium Analyzer

K830805510(k) TraditionalCleared Apr 8, 198325-day reviewClass I21 CFR 866.2300

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

Radiometer America, Inc. · JSG Culture Media, Non-Selective And Non-Differential

Cleared on Apr 8, 1983 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 8, 1983
Review
25 days
Class
Class I
Product code
JSG
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2021: 1 descendant cleared19801990200020102020
  1. This deviceK830805 Knai Sodium Potassium AnalyzerRadiometer America, Inc. · 1983
  2. Descendant · cites it directly · 1 of its ownK992140 Piccolo Metlyte 7 Reagent DiscAbaxis, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK200865 Piccolo Potassium Test SystemAbaxis, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc. · 1999 · cites it directly1descendant
  • K200865Piccolo Potassium Test SystemAbaxis, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K830805Knai Sodium Potassium AnalyzerRadiometer America, Inc.1983—
+1K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc.19992
+2K200865Piccolo Potassium Test SystemAbaxis, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
202110
FIG. 1 — Lineage of K830805, 1983–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JSG? 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
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc.19991

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.

What does this lineage say?

  • Of its descendants, K992140 (Abaxis, Inc., 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JSG devices

JSG Culture Media, Non-Selective And Non-Differential: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSG

FDA has decided no JSG device since 2007.

Median 510(k) review, days · JSG

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

Recalls per year · JSG

1in 2018

2014: 22018: 1
2007high 2 (2014) · low 0 (2007)2026

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

Adverse event reports per year · JSG

228in 2025

2008: 42010: 32011: 12012: 72013: 12014: 12016: 12017: 32019: 252020: 12021: 1772022: 1982023: 1822024: 322025: 228
2007high 228 (2025) · low 0 (2007)2025

MAUDE reports naming product code JSG, 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—04
20090—00
20100—03
20110—01
20120—07
20130—01
20140—21
20150—00
20160—01
20170—03
20180—10
20190—025
20200—01
20210—0177
20220—0198
20230—0182
20240—032
20250—0228
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 JSG

The JSG category page

  • K882495Thioglycollate Broth W/Vita. K & Hemin - #T3007Lakewood Biochemical Co., Inc. · 1988
  • K881557TryptoneAcumedia Manufacturers, Inc. · 1988
  • K881545Malt ExtractAcumedia Manufacturers, Inc. · 1988
  • K881548MPH AgarAcumedia Manufacturers, Inc. · 1988
  • K881546Malt Extract AgarAcumedia Manufacturers, Inc. · 1988

https://510kreport.com/device/K830805 · printed Nov 3, 2026

Cite this page

510(k) Report. “K830805: Knai Sodium Potassium Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830805

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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