HTRClass I

Rasp

21 CFR 878.4800 / General, Plastic Surgery

HTR is the FDA product code for Rasp, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 1987-02-13, and 2 recalls.

Classification record

Product code: HTR
Device name: Rasp
Regulation: 21 CFR 878.4800
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 2

Clearances, product code HTR

By decision year

9 clearances under product code HTR with a decision year between 1976 and 1987, 1987 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HTR by decision year
Year	Clearances
1976	1
1977	1
1978	2
1981	2
1987	3

Applicants with the most clearances

Product code HTR

Applicants holding the most 510(k) clearances under product code HTR
Applicant	Clearances
Biodynamic Technologies, Inc.	3
Amsco Co.	1
Depuy, Inc.	1
Dyonics, Inc.	1
Howmedica Corp.	1
Orthopedic Equipment Co., Inc.	1
Richard'S Medical Equip., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 250 companies shown, in name order