510(k) Report

510(k) · Cleared

Recalled · 2009

Transcutaneous O2/CO2 Monitor

K890517510(k) TraditionalCleared Apr 14, 198974-day reviewClass II21 CFR 868.2480Recalls 4

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

Novametrix Medical Systems, Inc. · LKD Monitor, Carbon-Dioxide, Cutaneous

Cleared on Apr 14, 1989 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 4 times.

Decided
Apr 14, 1989
Review
74 days
Class
Class II
Product code
LKD
Recalls
4
Predicates
0

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

FIG. 1 — Lineage of K890517Source: 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 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
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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)

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2009Not classifiedZ-1270-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1288-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1272-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1271-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…

No ancestor or descendant has a Class I recall.

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 Novametrix Medical Systems, Inc.

58 FDA decisions under this applicant name. See the company

  • K010451Novametrix Marquette Compatible SensorsNovametrix Medical Systems, Inc. · 2001
  • K000794Modification to MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20005 recalls
  • K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20001 recall
  • K982499Cosmo Plus with Nico, Model 8200Novametrix Medical Systems, Inc. · 19981 recall
  • K964360Vent (Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101Novametrix Medical Systems, Inc. · 1997

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/K890517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K890517: Transcutaneous O2/CO2 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K890517

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