510(k) · Cleared
ClearedProctigard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Pharmaceuticals, Inc. · PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Cleared on Jul 16, 2014 as substantially equivalent to K062795 (Access Pharmaceuticals, Inc., 2006) after a 133-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 16, 2014
- Review
- 133 days
- Class
- Class U
- Product code
- PHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964852 (1997). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK964852 Radiacare Oral Wound RinseCarrington Laboratories, Inc. · 1997
- 2 generations backK024180 Oramagicrx Oral Wound RinseMpm Medical., Inc. · 2003
- 1 generation backK062795 Mugard Mucoadhesive Oral Wound RinseAccess Pharmaceuticals, Inc. · 2006
- This deviceK140558 ProctigardAccess Pharmaceuticals, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK213552 PuraStat-RM3-D Matrix, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK242634 PuraStat3-D Matrix Europe SAS · 2025
- Descendant · 3 generations on · 1 of its ownK253923 PuraStat3-D Matrix Europe SAS · 2026
- Descendant · 2 generations on · 0 of its ownK261504 PuraStat-RM3-D Matrix, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964852 | Radiacare Oral Wound Rinse | Carrington Laboratories, Inc. | 1997 | — |
| −2 | K024180 | Oramagicrx Oral Wound Rinse | Mpm Medical., Inc. | 2003 | — |
| −1 | K062795 | Mugard Mucoadhesive Oral Wound Rinse | Access Pharmaceuticals, Inc. | 2006 | — |
| 0 (this device) | K140558 | Proctigard | Access Pharmaceuticals, Inc. | 2014 | — |
| +1 | K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022 | — |
| +2 | K242634 | PuraStat | 3-D Matrix Europe SAS | 2025 | — |
| +3 | K253923 | PuraStat | 3-D Matrix Europe SAS | 2026 | — |
| +2 | K261504 | PuraStat-RM | 3-D Matrix, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K062795 | Mugard Mucoadhesive Oral Wound RinseSummary page 1…owing predicate device: *MuGard®D Mucoadhesive Oral Wound Dressing manufactured by Access Pharmaceuticals, Inc. and cleared for commercial distribution under 510(k) K062795. 5.4 Device Description ProctiGardTM is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the sy… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213552 | PuraStat-RM | 2022 | 3 |
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 17 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K213552 (3-D Matrix, Inc., 2022) has gone furthest, with 3 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. 2014, 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?
ProcticardTM is indicated for the symptomatic management of rectal mucositis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140558: Proctigard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140558
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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