510(k) · Cleared
ClearedPeriflux 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perimed AB · LKD Monitor, Carbon-Dioxide, Cutaneous
Cleared on Oct 22, 2013 as substantially equivalent to K043003 (Radiometer Medical Aps, 2005) and 1 other predicate after a 173-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Oct 22, 2013
- Review
- 173 days
- Class
- Class II
- Product code
- LKD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001866 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK001866 TCM400Radiometer Medical A/S · 2000 · Recalled
- This deviceK131253 Periflux 6000Perimed AB · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001866 | TCM400 | Radiometer Medical A/S | 2000 | 3 |
| 0 (this device) | K131253 | Periflux 6000 | Perimed AB | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K232516 Sentec Digital Monitoring System (SDMS) tCOM+score 10.1 · 10 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043003 | TCM40 Monitoring SystemSummary page 1…_ Predicate Device Information Predicate Device No 1 Trade name: TCM4 Monitoring System 510(k) No: K043003 Type of product: Finished product Panel: Anesthesiology Common… | 2005 |
| * | K001866 | TCM400Summary page 2…Obj eO'' bjxo PeniFlux 6000 - 510(k) Summary Predicate Device No 2 Trade name: TCM400 5 10(k) No: K001866 Type of product: Finished product Panel: Anesthesiology… | 2000 |
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.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K043003.
How does its category compare?
All LKD devicesLKD Monitor, Carbon-Dioxide, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LKD
1in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKD
3in 2025
MAUDE reports naming product code LKD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 1 | 21 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PeniFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131253: Periflux 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131253
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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