Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teledyne Water Pik — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
186 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970594 | KALGINATE IMPRESSION MATERIAL | Teledyne Water Pik | 1997-03-31 | 41 | 0 |
| K952422 | ELASTIC IMPRESSION CREAM | Teledyne Water Pik | 1995-08-29 | 98 | 0 |
| K944162 | DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM | Teledyne Water Pik | 1994-11-29 | 95 | 0 |
| K940288 | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT | Teledyne Water Pik | 1994-05-26 | 125 | 0 |
| K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik | 1993-09-20 | 186 | 0 |
| K905188 | PERIO PIK | Teledyne Water Pik | 1991-02-15 | 88 | 0 |
| K900547 | WATER PIK(R) W/ADD'L CLAIMS | Teledyne Water Pik | 1990-06-15 | 130 | 0 |
| K895259 | PIK POCKET(R), MODEL PP-3 | Teledyne Water Pik | 1989-11-01 | 152 | 0 |
| K894015 | WATER PIK(R) | Teledyne Water Pik | 1989-08-28 | 83 | 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