510(k) · Cleared
ClearedDermapose Access
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puregraft, LLC · QPB System, Suction, Lipoplasty For Removal
Cleared on Apr 22, 2020 as substantially equivalent to K142073 (Thiebaud Sas, 2015) after a 90-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Apr 22, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K861878 (1986). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK861878 Byron Suction TipsByron Medical · 1986
- 4 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
- 3 generations backK990602 Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999
- 2 generations backK060089 Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006
- 1 generation backK142073 ST'RIMThiebaud Sas · 2015
- This deviceK200168 Dermapose AccessPuregraft, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861878 | Byron Suction Tips | Byron Medical | 1986 | — |
| −4 | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles | Byron Medical | 1998 | — |
| −3 | K990602 | Richter Lipoplasty Cannulas and Accessories | Tecsa Technical Services | 1999 | — |
| −2 | K060089 | Tulip Disposable Cannulas | Cell Bio-Systems, Inc. | 2006 | — |
| −1 | K142073 | ST'RIM | Thiebaud Sas | 2015 | — |
| 0 (this device) | K200168 | Dermapose Access | Puregraft, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 QPB? 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 QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K142073 | ST'RIMSummary page 5…MUU Regulatory Class: Class II Classification Regulation: 21 CFR 878.5040 Panel: General & Plastic Surgery Predicate Device st’rim, K142073, Thiebaud SAS Indications for Use The DermaposeTM Access fat harvest system is intended for use in aesthetic body contouring.… | 2015 |
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 34 years and passes through 5 companies; a new generation was cleared every 6.8 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
The Dermapose Access fat harvest system is intended for use in aesthetic body contouring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200168: Dermapose Access.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200168
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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