510(k) Report

510(k) · Cleared

Cleared

PuraStat-RM

K261504510(k) TraditionalCleared Aug 3, 202689-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

3-D Matrix, Inc. · PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

Cleared on Aug 3, 2026 as substantially equivalent to K213552 (3-D Matrix, Inc., 2022) and 2 other predicates after an 89-day review. Its family tree reaches back 7 generations to 1997.

Decided
Aug 3, 2026
Review
89 days
Class
Class U
Product code
PHN
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K964852 (1997). 14 ancestors in all, the oldest K933741 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2021: 1 other ancestor2007: 1 other ancestor2001: 2 other ancestors1998: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK964852 · Radiacare Oral Wound Rinse · Carrington Laboratories, Inc. · 1997K024180 · Oramagicrx Oral Wound Rinse · Mpm Medical., Inc. · 2003K062795 · Mugard Mucoadhesive Oral Wound Rinse · Access Pharmaceuticals, Inc. · 2006K140558 · Proctigard · Access Pharmaceuticals, Inc. · 2014K213552 · PuraStat-RM · 3-D Matrix, Inc. · 2022K242634 · PuraStat · 3-D Matrix Europe SAS · 2025K253923 · PuraStat · 3-D Matrix Europe SAS · 20261990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 5 other ancestors K253923 · PuraStat · 3-D Matrix Europe SAS · 2026K242634 · PuraStat · 3-D Matrix Europe SAS · 2025K213552 · PuraStat-RM · 3-D Matrix, Inc. · 2022K140558 · Proctigard · Access Pharmaceuticals, Inc. · 2014K062795 · Mugard Mucoadhesive Oral Wound Rinse · Access Pharmaceuticals, Inc. · 2006K024180 · Oramagicrx Oral Wound Rinse · Mpm Medical., Inc. · 2003K964852 · Radiacare Oral Wound Rinse · Carrington Laboratories, Inc. · 1997−50
  1. Root · 7 generations backK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
  2. 6 generations backK024180 Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
  3. 5 generations backK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
  4. 4 generations backK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
  5. 3 generations backK213552 PuraStat-RM3-D Matrix, Inc. · 2022
  6. 2 generations backK242634 PuraStat3-D Matrix Europe SAS · 2025
  7. 1 generation backK253923 PuraStat3-D Matrix Europe SAS · 2026
  8. This deviceK261504 PuraStat-RM3-D Matrix, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K964852Radiacare Oral Wound RinseCarrington Laboratories, Inc.1997—
−6K024180Oramagicrx Oral Wound RinseMpm Medical., Inc.2003—
−5K062795Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc.2006—
−4K140558ProctigardAccess Pharmaceuticals, Inc.2014—
−3K213552PuraStat-RM3-D Matrix, Inc.2022—
−2K242634PuraStat3-D Matrix Europe SAS2025—
−1K253923PuraStat3-D Matrix Europe SAS2026—
0 (this device)K261504PuraStat-RM3-D Matrix, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199810
200120
200710
202110
FIG. 1 — Lineage of K261504, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242634 PuraStatscore 15.9 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K213552PuraStat-RM
Summary page 5
…ssified Regulatory Class: Unclassified Product Code: PHN Panel: Gastroenterology / Urology 3. PREDICATE DEVICES Primary predicate: 3-D Matrix Inc. PuraStat-RM (K213552) Additional predicates: 3-D Matrix Europe SAS PuraStat (K242634, K253923) 4. DEVICE DESCRIPTION PuraStat-RM is a steril…
3-D Matrix, Inc.2022—
*K242634PuraStat
Summary page 5
…Gastroenterology / Urology 3. PREDICATE DEVICES Primary predicate: 3-D Matrix Inc. PuraStat-RM (K213552) Additional predicates: 3-D Matrix Europe SAS PuraStat (K242634, K253923) 4. DEVICE DESCRIPTION PuraStat-RM is a sterile gel composed of a synthetic peptide and sterile water for inje…
3-D Matrix Europe SAS2025—
*K253923PuraStat
Summary page 5
…erology / Urology 3. PREDICATE DEVICES Primary predicate: 3-D Matrix Inc. PuraStat-RM (K213552) Additional predicates: 3-D Matrix Europe SAS PuraStat (K242634, K253923) 4. DEVICE DESCRIPTION PuraStat-RM is a sterile gel composed of a synthetic peptide and sterile water for injection. It…
3-D Matrix Europe SAS2026—

Also cleared against K213552: 1 other device →

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 3.7 years on median.
  • None of the 14 ancestors has a recall.
  • 1 other device also cites its predicate K213552.

How does its category compare?

All PHN devices

PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · PHN

2so far in 2026, the most since 2007

2014: 12022: 12025: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20251—00
20262—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 as stated in the FDA summary.

Also cleared against K213552

1 other device cites the same predicate.

  • K242634PuraStat3-D Matrix Europe SAS · 2025

More from 3-D Matrix, Inc.

9 FDA decisions under this applicant name. See the company

  • K261503PuraStat GI3-D Matrix, Inc. · 2026
  • K222481PuraStat3-D Matrix, Inc. · 2023
  • K213552PuraStat-RM3-D Matrix, Inc. · 2022
  • K210211PuraStat-OM3-D Matrix, Inc. · 2021
  • K210098PuraStat-GI3-D Matrix, Inc. · 2021

Recent decisions in PHN

The PHN category page

  • K253923PuraStat3-D Matrix Europe SAS · 2026
  • K242634PuraStat3-D Matrix Europe SAS · 2025
  • K213552PuraStat-RM3-D Matrix, Inc. · 2022
  • K140558ProctigardAccess Pharmaceuticals, Inc. · 2014

https://510kreport.com/device/K261504 · printed Nov 5, 2026

Cite this page

510(k) Report. “K261504: PuraStat-RM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261504

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026