Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ptw-New York Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
732 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062817 | PTW DAVID IMRT QC VERIFICATION SYSTEM | Ptw-New York Corp. | 2006-11-22 | 63 | 0 |
| K010705 | OPTIDOS | Ptw-New York Corp. | 2003-03-11 | 732 | 0 |
| K010916 | PTW DOSIMETRY DIODE, T60008 | Ptw-New York Corp. | 2001-06-20 | 85 | 0 |
| K972211 | MULTIDOS, QC6PLUS | Ptw-New York Corp. | 1997-09-10 | 90 | 0 |
| K972212 | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZ | Ptw-New York Corp. | 1997-09-10 | 90 | 0 |
| K961208 | 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMB | Ptw-New York Corp. | 1996-06-17 | 83 | 0 |
| K954165 | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM | Ptw-New York Corp. | 1995-12-05 | 91 | 0 |
| K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 1 | Ptw-New York Corp. | 1995-10-07 | 173 | 1 |
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