Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Astra Tech AB — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
435 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121810 | OSSEOSPEED ANGLED ABUTMENT EV | Astra Tech AB | 2013-01-23 | 217 | 0 |
| K120414 | OSSEOSPEED PLUS | Astra Tech AB | 2012-07-31 | 172 | 0 |
| K113424 | LOFRIC SINGLE USE URINARY CATHETER | Astra Tech AB | 2012-04-17 | 148 | 0 |
| K111287 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | 2011-09-26 | 143 | 0 |
| K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Astra Tech AB | 2011-06-21 | 435 | 0 |
| K101732 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | 2011-02-23 | 247 | 0 |
| K091239 | ASTRA TECH IMPLANT SYSTEM | Astra Tech AB | 2009-09-22 | 148 | 0 |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | Astra Tech AB | 2008-09-17 | 238 | 0 |
| K080396 | OSSEOSPEED NARROW | Astra Tech AB | 2008-04-30 | 77 | 0 |
| K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | Astra Tech AB | 2007-10-01 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda