510(k) · Cleared
ClearedLifetech Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifetech Systems, Inc. · KPJ Chamber, Oxygen, Topical, Extremity
Cleared on Aug 29, 1997 as substantially equivalent to K920948 (Topox Therapeuutic Rentals, Inc., 1992) after a 553-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 29, 1997
- Review
- 553 days
- Class
- Class II
- Product code
- KPJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920948 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920948 Topical Sacral Hyperbaric Oxygen ChamberTopox Therapeuutic Rentals, Inc. · 1992
- This deviceK960756 Lifetech CassetteLifetech Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920948 | Topical Sacral Hyperbaric Oxygen Chamber | Topox Therapeuutic Rentals, Inc. | 1992 | — |
| 0 (this device) | K960756 | Lifetech Cassette | Lifetech Systems, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K920948 | Topical Sacral Hyperbaric Oxygen ChamberSummary page 1…r "Topical Oxygen Chamber for Extremities”. The device is also substantially equivalent to several oxygen chambers used for topical purposes, for example that cleared by K920948. The "510(k) "Substantial Equivalence” Decision-Making Process (Detailed) from (repl. p. 7) 88/13/1996 12:43 3… | 1992 |
| * | — | Topical Oxygen Chamber for Extremities Named without a submission number |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K920948.
How does its category compare?
All KPJ devicesKPJ Chamber, Oxygen, Topical, Extremity: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Surgical wounds, non-healing
Bums,
Pressure Ulcers
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960756: Lifetech Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960756
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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