510(k) · Cleared
ClearedTembo Embolic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instylla, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Dec 15, 2025 as substantially equivalent to K240873 (Instylla, Inc., 2024) after a 24-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Dec 15, 2025
- Review
- 24 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K961923 (1996). 10 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 6 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 5 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 4 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 3 generations backK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · Recalled
- 2 generations backK183120 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019
- 1 generation backK240873 TEMBO Embolic SystemInstylla, Inc. · 2024
- This deviceK253677 Tembo Embolic SystemInstylla, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −6 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −5 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −4 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −3 | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | 1 |
| −2 | K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019 | — |
| −1 | K240873 | TEMBO Embolic System | Instylla, Inc. | 2024 | — |
| 0 (this device) | K253677 | Tembo Embolic System | Instylla, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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 |
|---|---|---|---|
| * | K240873 | TEMBO Embolic SystemSummary page 5…oprietary Name: TEMBO Embolic System Manufacturer: Instylla, Inc. 510(k) Number: K240873 Device Description: The Tembo Embolic System consists of biocompatible, dry resorbable particles of porcine gelatin in a 10 mL s… | 2024 |
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 2.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
The Tembo Embolic System is a gelatin agent intended for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253677 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253677: Tembo Embolic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253677
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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