510(k) · Cleared
ClearedEMBA Hourglass Peripheral Embolization Device (PED)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embolic Acceleration, LLC · KRD Device, Vascular, For Promoting Embolization
Cleared on Feb 14, 2020 as substantially equivalent to K171845 (Emba Medical Limited, 2017) after a 30-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Feb 14, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K171845 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK171845 EMBA Hourglass Peripheral Embolization DeviceEmba Medical Limited · 2017
- This deviceK200083 EMBA Hourglass Peripheral Embolization Device (PED)Embolic Acceleration, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K171845 | EMBA Hourglass Peripheral Embolization Device | Emba Medical Limited | 2017 | — |
| 0 (this device) | K200083 | EMBA Hourglass Peripheral Embolization Device (PED) | Embolic Acceleration, LLC | 2020 | — |
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 |
|---|---|---|---|
| * | K171845 | EMBA Hourglass Peripheral Embolization DeviceSummary page 4…mbolization Classification Name: Vascular embolization device Predicate Device: EMBA Hourglass™ Peripheral Embolization Device (K171845) 510(k) Number: K200083 Product Code: KRD Device Class: Class II Regulation Number:… | 2017 |
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?
- Its one ancestor has no recall.
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. 2020, 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 EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200083 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200083: EMBA Hourglass Peripheral Embolization Device (PED).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200083
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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