Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wfr/Aquaplast Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
218 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120916 | QFIX RADIOTHERAPY CHAIR | Wfr/Aquaplast Corp. | 2012-06-20 | 85 | 0 |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND A | Wfr/Aquaplast Corp. | 2006-05-04 | 51 | 0 |
| K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILE | Wfr/Aquaplast Corp. | 2003-09-02 | 50 | 0 |
| K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER | Wfr/Aquaplast Corp. | 2002-07-02 | 85 | 0 |
| K973370 | AQUAPLAST PALATAL STENT | Wfr/Aquaplast Corp. | 1997-12-02 | 85 | 0 |
| K943871 | AQUAPLAST TIE DOWN DRESSING | Wfr/Aquaplast Corp. | 1994-09-30 | 53 | 0 |
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND S | Wfr/Aquaplast Corp. | 1994-07-29 | 87 | 0 |
| K935067 | AQUAPLAST | Wfr/Aquaplast Corp. | 1994-05-26 | 218 | 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