510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K100974Substantially Equivalent

Spectrum Turbo-Ject Picc Set

Cook Incorporated, Bloomington IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100974 is the FDA 510(k) clearance record for SPECTRUM TURBO-JECT PICC SET, a class II device, cleared for Cook Incorporated on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K100974.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FOZ

Trailing 12 months
8 clearances under product code FOZ in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260
November 20260