510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895259Substantially Equivalent

Pik Pocket(r), Model Pp-3

Teledyne Water Pik, Fort Collins CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895259 is the FDA 510(k) clearance record for PIK POCKET(R), MODEL PP-3, a class I device, cleared for Teledyne Water Pik on under FDA product code EFS (Unit, Oral Irrigation). FDA records list 9 510(k) clearances for Teledyne Water Pik, from to . As of , FDA records show no recalls naming K895259.

Clearance record

Decision date
Received
(152 days to decision)
Product code
EFS Unit, Oral Irrigation
Regulation
21 CFR 872.6510
Device class
Class I
Review panel
Dental
Applicant
Teledyne Water Pik 1730 E. Prospect Rd., Fort Collins CO
Third party review
No

Clearances, product code EFS

Trailing 12 months

FDA records hold no clearances under product code EFS in the trailing twelve months.

FDA records show no clearances under product code EFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260