Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Penumbra with 88 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Oct 15, 2026: INDIGO® Aspiration System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 15, 2026 | INDIGO® Aspiration SystemK262904 · QEW | 510(k) clearances |
| Jun 10, 2026 | Penumbra System (Thunderbolt Aspiration Tubing)K250690 · NRY | 510(k) clearances |
| Jun 3, 2026 | Penumbra System RED 68 Reperfusion Catheter REF: RED68KITClass II · Due to manufacturing issues, reperfusion catheters may fractures | Device recalls |
| Apr 24, 2026 | INDIGO® Aspiration System – INDIGO LinkK260599 · QEW | 510(k) clearances |
| Feb 5, 2026 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKK251949 · QEW | 510(k) clearances |
| Oct 16, 2025 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingK252612 · QEW | 510(k) clearances |
| Mar 14, 2025 | Ruby XL SystemK250079 · KRD | 510(k) clearances |
| Feb 13, 2025 | Penumbra System (Reperfusion Catheter RED 72)K242104 · NRY | 510(k) clearances |
| Dec 11, 2024 | Access25™ Delivery MicrocatheterK242033 · QJP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
