510(k) · Cleared
Recalled · Class II · 2017Monoswift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Oct 5, 2007 as substantially equivalent to K002190 (Cp Medical, 2000) and 2 other predicates after a 56-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- Oct 5, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K960653 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
- This deviceK072229 MonoswiftCp Medical · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) | ETHICON, Inc. | 1996 | 2 |
| 0 (this device) | K072229 | Monoswift | Cp Medical | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002190 | Polyglycolic Acid (Pga), Absorbable Surgical Suture (Usp)Summary page 1…Absorbable Suture, Synthetic, Polyglycolic Acid (GAM) Device Classification: Class II, 21 CFR 878.4493 Predicate Devices: CP Medical Visorb, K002190 Ethicon Monocryl, K960053 (dyed), K964072 (undyed) Manufacturer: CP Medical… | 2000 |
| * | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) Our reading of the summary gave K960053, FDA’s number for Selfcare Blood Glucose Test Strips for the Exactech System (Selfcare, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ethicon Monocryl (dyed)”. | 1996 |
| * | K964072 | Monocryl (Poliglecaprone 25) Suture, UndyedSummary page 1…ation: Class II, 21 CFR 878.4493 Predicate Devices: CP Medical Visorb, K002190 Ethicon Monocryl, K960053 (dyed), K964072 (undyed) Manufacturer: CP Medical 803 NE 25th Ave.… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2017 | Class II | Z-1872-2017 | Unknown/Undetermined by firm | The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 3 of the 3 ancestors have a recall of any class.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Monoswift TM is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072229: Monoswift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072229
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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