Hu-Friedy Mfg. Co., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hu-Friedy Mfg. Co., Inc.” (first 1984, latest 2012), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 246 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 5 | 5 |
| EJI | Syringe, Cartridge | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| EKM | Gutta-Percha | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
Review panels
Most recent Hu-Friedy Mfg. Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | EJI | 2012-11-06 | 246 |
| K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | ELC | 2010-03-30 | 42 |
| K073369 | EI DOWNPAK BARRIER SLEEVES | EKM | 2008-02-27 | 89 |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | ELC | 2007-06-21 | 76 |
| K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | ELC | 2006-02-01 | 79 |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | ELC | 2001-07-27 | 25 |
| K953919 | DENTAL ULTRASONIC SCALER INSERTS | ELC | 1995-10-07 | 47 |
| K912473 | ACCU-PLACER TM KIT | EKJ | 1991-07-24 | 50 |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | FSM | 1984-11-08 | 27 |
Recalls
8 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2005-01-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hu-Friedy Mfg. Co., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Hu-Friedy Mfg. Co., Inc.” (first 1984, latest 2012), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hu-Friedy Mfg. Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hu-Friedy Mfg. Co., Inc. is 50 days.
Which FDA product codes appear under Hu-Friedy Mfg. Co., Inc.?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 5); EJI (Syringe, Cartridge, 1); EKJ (Burnisher, Operative, 1).
Next steps
- See all 9 Hu-Friedy Mfg. Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELC, Hu-Friedy Mfg. Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.