HTPClass I

File

21 CFR 888.4540 / Orthopedic

HTP is the FDA product code for File, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1994-01-26, and no recalls.

Classification record

Product code: HTP
Device name: File
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: 5
Ingested recalls: 0

Clearances, product code HTP

By decision year

5 clearances under product code HTP with a decision year between 1984 and 1994, 1984 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HTP by decision year
Year	Clearances
1984	2
1986	1
1987	1
1994	1

Applicants with the most clearances

Product code HTP

Applicants holding the most 510(k) clearances under product code HTP
Applicant	Clearances
Concept, Inc.	1
Intermedics Orthopedics	1
Stainless Mfg., Inc.	1
Suncoast Medical Manufacturers, Inc.	1
Warsaw Orthopedic, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 73 companies shown, in name order

Recent clearances

Product code HTP

Recent recalls

Product code HTP

FDA records show no recalls under product code HTP.

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)