IWRClass I

Holder, Syringe, Lead

21 CFR 892.6500 / Radiology

IWR is the FDA product code for Holder, Syringe, Lead, a class I device type, regulated under 21 CFR 892.6500. As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 1994-02-19, and no recalls.

Classification record

Product code: IWR
Device name: Holder, Syringe, Lead
Regulation: 21 CFR 892.6500
Device class: Class I
Review panel: Radiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code IWR

By decision year

4 clearances under product code IWR with a decision year between 1981 and 1994, 1987 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code IWR by decision year
Year	Clearances
1981	1
1987	2
1994	1

Applicants with the most clearances

Product code IWR

Applicants holding the most 510(k) clearances under product code IWR
Applicant	Clearances
Viox Corp.	2
Medi-Physics Inc. dba Nycomed Amersham Imaging	1
Victoreen, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order

Recent clearances

Product code IWR

Recent recalls

Product code IWR

FDA records show no recalls under product code IWR.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)