510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050112Substantially Equivalent

Pro Fit Disposable Rectal Speculum, Models 8116 and 8117

Prime Pacific Health Innovations Corporation, North Vancouver, Bc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050112 is the FDA 510(k) clearance record for PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117, a class II device, cleared for Prime Pacific Health Innovations Corporation on under FDA product code KPL (Colonic Irrigation System). FDA records list 2 510(k) clearances for Prime Pacific Health Innovations Corporation, from to . As of , FDA records show no recalls naming K050112.

Clearance record

Decision date
Received
(56 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Prime Pacific Health Innovations Corporation 8-145 Riverside Dr., North Vancouver, Bc, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPL

Trailing 12 months

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

FDA records show no clearances under product code KPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPL, 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