HXBClass I

Probe

21 CFR 888.4540 / Orthopedic

HXB is the FDA product code for Probe, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 15 510(k) clearances under this code, the most recent dated 1996-07-23, and 3 recalls.

Classification record

Product code: HXB
Device name: Probe
Regulation: 21 CFR 888.4540
Device class: Class I
Review panel: Orthopedic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 15
Ingested recalls: 3

Clearances, product code HXB

By decision year

15 clearances under product code HXB with a decision year between 1980 and 1996, 1980 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code HXB by decision year
Year	Clearances
1980	5
1981	1
1984	2
1986	1
1987	2
1989	1
1991	1
1994	1
1996	1

Applicants with the most clearances

Product code HXB

Applicants holding the most 510(k) clearances under product code HXB
Applicant	Clearances
Arthropedics, Inc.	2
Stainless Mfg., Inc.	2
Acufex Microsurgical, Inc.	1
Bowen & Company, Inc.	1
Cohort Medical Products Group, Inc.	1
Concept, Inc.	1
Eder Instrument Co, Inc.	1
Flexmedics	1
Hogan & Hartson	1
Instranetics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 348 companies shown, in name order