510(k) · Cleared
ClearedPuraStat-RM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3-D Matrix, Inc. · PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Cleared on Apr 1, 2022 as substantially equivalent to K140558 (Access Pharmaceuticals, Inc., 2014) and 1 other predicate after a 144-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- Apr 1, 2022
- Review
- 144 days
- Class
- Class U
- Product code
- PHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964852 (1997). 11 ancestors in all, the oldest K933741 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
- 3 generations backK024180 Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
- 2 generations backK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
- 1 generation backK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
- This deviceK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK242634 PuraStat3-D Matrix Europe SAS · 2025
- Descendant · 2 generations on · 1 of its ownK253923 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · cites it directly · 0 of its ownK261504 PuraStat-RM3-D Matrix, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964852 | Radiacare Oral Wound Rinse | Carrington Laboratories, Inc. | 1997 | — |
| −3 | K024180 | Oramagicrx Oral Wound Rinse | Mpm Medical., Inc. | 2003 | — |
| −2 | K062795 | Mugard Mucoadhesive Oral Wound Rinse | Access Pharmaceuticals, Inc. | 2006 | — |
| −1 | K140558 | Proctigard | Access Pharmaceuticals, Inc. | 2014 | — |
| 0 (this device) | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +1 | K242634 | PuraStat | 3-D Matrix Europe SAS | 2025 | — |
| +2 | K253923 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +1 | K261504 | PuraStat-RM | 3-D Matrix, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 PHN? 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 PHN device
- #1 K242634 PuraStatscore 15.9 · 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? (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 |
|---|---|---|---|
| * | K140558 | ProctigardSummary page 4…tory Class: Unclassified Product Code: PHN Panel: Gastroenterology / Urology 3. PREDICATE DEVICE Predicate Devices: Access Pharmaceuticals, Inc.’s ProctiGard (K140558) and 3-D Matrix Inc.’s PuraStat-OM (K210211) Reference Device: 3-D Matrix, Inc.’s PuraStat-GI (K210098) 4. DEVICE DESC… | 2014 |
| * | K210211 | PuraStat-OMSummary page 4…anel: Gastroenterology / Urology 3. PREDICATE DEVICE Predicate Devices: Access Pharmaceuticals, Inc.’s ProctiGard (K140558) and 3-D Matrix Inc.’s PuraStat-OM (K210211) Reference Device: 3-D Matrix, Inc.’s PuraStat-GI (K210098) 4. DEVICE DESCRIPTION PuraStat-RM is a sterile gel compose… | 2021 |
| † | K210098 | PuraStat-GI | 2021 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K242634 (3-D Matrix Europe SAS, 2025) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PHN devicesPHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PHN
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PHN
Too few PHN 510(k)s in any year since 2007 to give a median.
Recalls per year · PHN
No recall names PHN since 2007.
Adverse event reports per year · PHN
No MAUDE report names PHN 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PuraStat-RM is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
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/K213552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213552: PuraStat-RM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213552
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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