510(k) · Cleared
ClearedNatrox Topical Oxygen Delivery System with Iodp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inotec Amd, Ltd. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Jul 3, 2012 as substantially equivalent to K023456 (Oxyfast Corporation, 2003) and 1 other predicate after a 298-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Jul 3, 2012
- Review
- 298 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K831825 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK831825 Dispos. Hyperbaric Oxygen Cush/TraumHospitak, Inc. · 1983
- 3 generations backK971507 O2 BOOTGwr Medical, Llp · 1997
- 2 generations backK023456 Oxybox SystemOxyfast Corporation · 2003 · Recalled
- 1 generation backK090681 Tanscu O2Electrochemical Oxygen Concepts, Inc. · 2009
- This deviceK112634 Natrox Topical Oxygen Delivery System with IodpInotec Amd, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831825 | Dispos. Hyperbaric Oxygen Cush/Traum | Hospitak, Inc. | 1983 | — |
| −3 | K971507 | O2 BOOT | Gwr Medical, Llp | 1997 | — |
| −2 | K023456 | Oxybox System | Oxyfast Corporation | 2003 | 2 |
| −1 | K090681 | Tanscu O2 | Electrochemical Oxygen Concepts, Inc. | 2009 | — |
| 0 (this device) | K112634 | Natrox Topical Oxygen Delivery System with Iodp | Inotec Amd, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 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 KPJ? 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 KPJ device
- #1 K250188 Wound Treatment System (VHT-200)score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K023456 | Oxybox SystemSummary page 1…Equivalence This 5 10(k) submission demonstrates that the NATROXTM Topical Oxygen Delivery System is substantially equivalent to the Oxybox System (Oxyfast Corporation, K023456) and the TransCu 02 (Electrochemical Oxygen Concepts, Inc., K09068 1), which are similar in both technology and intended use to t… | 2003 |
| * | K090681 | Tanscu O2Summary page 1…Topical Oxygen Delivery System is substantially equivalent to the Oxybox System (Oxyfast Corporation, K023456) and the TransCu 02 (Electrochemical Oxygen Concepts, Inc., K09068 1), which are similar in both technology and intended use to the subject device. Device Description The NATROXTM Topical Oxygen De… | 2009 |
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?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K023456.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KPJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPJ
Too few KPJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPJ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPJ
No MAUDE report names KPJ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NATROX System is a low-dose tissue oxygenation system intended to provide
topical oxygen to aid in the healing of chronic wounds such as:
* Skin ulcerations due to diabetes, venous stasis, post-surgical infections and
gangrenous lesions,
* Decubitis ulcers (bedsores),
* Amputations/infected stumps,
* Skin grafts,
* Bums, and
* Frostbite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112634: Natrox Topical Oxygen Delivery System with Iodp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112634
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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