510(k) Report

510(k) · Cleared

Cleared

E5280 Combined Transcutaneous TCP02/TCPCO2 Elect.

K900333510(k) TraditionalCleared Apr 16, 199083-day reviewClass II21 CFR 868.2480

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

Radiometer America, Inc. · LKD Monitor, Carbon-Dioxide, Cutaneous

Cleared on Apr 16, 1990 after an 83-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 16, 1990
Review
83 days
Class
Class II
Product code
LKD
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 2 descendants cleared1990200020102020
  1. This deviceK900333 E5280 Combined Transcutaneous TCP02/TCPCO2 Elect.Radiometer America, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK980756 Corometrics Transcutaneous TCPO2/CO2 ModuleGe Medical Systems Information Technologies · 1998
  3. Descendant · cites it directly · 0 of its ownK980287 Siemens SC9000/SC9015 TCP02/C02 ModuleSiemens Medical Solutions USA, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K980756Corometrics Transcutaneous TCPO2/CO2 ModuleGe Medical Systems Information Technologies · 1998 · cites it directly0descendants
  • K980287Siemens SC9000/SC9015 TCP02/C02 ModuleSiemens Medical Solutions USA, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900333E5280 Combined Transcutaneous TCP02/TCPCO2 Elect.Radiometer America, Inc.1990—
+1K980756Corometrics Transcutaneous TCPO2/CO2 ModuleGe Medical Systems Information Technologies1998—
+1K980287Siemens SC9000/SC9015 TCP02/C02 ModuleSiemens Medical Solutions USA, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
FIG. 1 — Lineage of K900333, 1990–1998Source: 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 LKD? 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 LKD device

  1. #1 K232516 Sentec Digital Monitoring System (SDMS) tCOM+score 10.1 · 10 generations · no Class I recall
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)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980756Corometrics Transcutaneous TCPO2/CO2 ModuleGe Medical Systems Information Technologies19980
K980287Siemens SC9000/SC9015 TCP02/C02 ModuleSiemens Medical Solutions USA, Inc.19980

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, K980756 (Ge Medical Systems Information Technologies, 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LKD devices

LKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKD

1in 2024

2010: 22011: 12013: 12015: 12024: 1
2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKD

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

Recalls per year · LKD

1in 2022

2009: 42011: 12012: 22014: 12016: 12022: 1
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · LKD

3in 2025

2010: 82012: 42013: 12014: 212015: 202016: 42019: 32020: 62021: 22023: 12024: 12025: 3
2007high 21 (2014) · low 0 (2007)2025

MAUDE reports naming product code LKD, 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—40
20102—08
20111—10
20120—24
20131—01
20140—121
20151—020
20160—14
20170—00
20180—00
20190—03
20200—06
20210—02
20220—10
20230—01
20241—01
20250—03
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 LKD

The LKD category page

  • K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
  • K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including…Sentec AG · 20159 recalls
  • K131253Periflux 6000Perimed AB · 2013
  • K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 20111 recall
  • K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 201012 recalls

https://510kreport.com/device/K900333 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900333: E5280 Combined Transcutaneous TCP02/TCPCO2 Elect..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900333

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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