510(k) Report

510(k) · Cleared

Cleared

Stat Profile Phox Plus L Analyzer

K023567510(k) AbbreviatedCleared Dec 20, 200258-day reviewClass II21 CFR 862.1120

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

Nova Biomedical Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Cleared on Dec 20, 2002 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Dec 20, 2002
Review
58 days
Class
Class II
Product code
CHL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK023567 Stat Profile Phox Plus L AnalyzerNova Biomedical Corp. · 2002
  2. Descendant · cites it directly · 1 of its ownK100602 Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test…Nova Biomedical Corp. · 2011
  3. Descendant · 2 generations on · 0 of its ownK112955 Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011 · cites it directly1descendant
  • K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023567Stat Profile Phox Plus L AnalyzerNova Biomedical Corp.2002—
+1K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp.2011—
+2K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
FIG. 1 — Lineage of K023567, 2002–2012Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CHL device

  1. #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp.20111

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, K100602 (Nova Biomedical Corp., 2011) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CHL devices

CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHL

1in 2025

2007: 12008: 12010: 12011: 42012: 42013: 52014: 32015: 42016: 32017: 12018: 12020: 42021: 22023: 52024: 12025: 12026 (partial year): 1
2007high 5 (2013) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CHL

267in 2023

2011: 108 days median2012: 65 days median2013: 152 days median2014: 68 days median2015: 155 days median2016: 306 days median2020: 100 days median2023: 267 days median
2007high 306 (2016) · low 65 (2012)2026

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

Recalls per year · CHL

13so far in 2026, the most since 2007

2007: 62008: 52009: 62010: 72011: 12012: 92013: 12014: 12015: 32016: 12017: 12018: 32020: 22023: 42024: 92026 (partial year): 13
2007high 13 (2026) · low 0 (2019)2026

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

Adverse event reports per year · CHL

210in 2025

2007: 162008: 402009: 742010: 202011: 502012: 642013: 622014: 932015: 552016: 1182017: 2062018: 1742019: 1412020: 1172021: 1472022: 1382023: 1772024: 1962025: 210
2007high 210 (2025) · low 16 (2007)2025

MAUDE reports naming product code CHL, 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—616
20081—540
20090—674
20101—720
20114108150
2012465964
20135152162
2014368193
20154155355
201633061118
20171—1206
20181—3174
20190—0141
202041002117
20212—0147
20220—0138
202352674177
20241—9196
20251—0210
20261—13—

What is it indicated for?

The Stat Profile pHOx Plus L Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care usage for the quantitative determination of pH, pC02, p02, S02%, Hct, Hb, Na+, K+, CI- (or Ca++), Glu and Lac in heparinized whole blood and Na+, K+, CI- (Qr Ca++), Glu and Lac in serum and heparinized plasma.

Indications for use as stated in the FDA 510(k) statement.

More from Nova Biomedical Corp.

89 FDA decisions under this applicant name. See the company

  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011
  • K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp. · 2010
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 201010 Class I recalls
  • K070960Nova Statstrip Xpress Glucose Hospital Meter SystemNova Biomedical Corp. · 20071 recall
  • K070255Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp. · 2007

Recent decisions in CHL

The CHL category page

  • K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps · 2026
  • K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 20251 recall
  • K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024
  • K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
  • K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2023

https://510kreport.com/device/K023567 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023567: Stat Profile Phox Plus L Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023567

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026