Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Optos Plc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
201 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233602 | P200TE (A10700) | Optos Plc. | 2024-05-09 | 182 | 0 |
| K231673 | P200TE (A10700) | Optos Plc. | 2023-08-18 | 71 | 0 |
| K190732 | P200TxE | Optos Plc. | 2019-07-31 | 132 | 0 |
| K173707 | P200TE | Optos Plc. | 2018-02-28 | 86 | 0 |
| K162039 | OptosAdvance 4.0 Software | Optos Plc. | 2017-02-08 | 201 | 0 |
| K142897 | P200DTx | Optos Plc. | 2015-01-16 | 105 | 0 |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | 2014-04-11 | 101 | 0 |
| K121043 | OPTOS OCT/SLO MICROPERIMETER | Optos Plc. | 2013-02-22 | 323 | 0 |
| K113696 | OPTOS ADVANCE | Optos Plc. | 2012-05-25 | 161 | 0 |
| K111628 | P200T | Optos Plc. | 2011-08-19 | 70 | 0 |
| K102492 | P200MAAF | Optos Plc. | 2010-09-30 | 30 | 0 |
| K100644 | OPTOS LIMITED PANORAMIC 200CAF | Optos Plc. | 2010-07-15 | 132 | 0 |
| K060424 | PANORAMIC, MODEL 200MA | Optos Plc. | 2006-03-17 | 28 | 0 |
| K042001 | PANORAMIC 200A | Optos Plc. | 2004-10-07 | 73 | 0 |
| K983999 | PANORAMIC200 OPTHALMOSCOPE | Optos Plc. | 1999-02-03 | 86 | 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