Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hu-Friedy Mfg. Co., Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
89 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | Hu-Friedy Mfg. Co., Inc. | 2010-03-30 | 42 | 0 |
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 | 89 | 0 |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | Hu-Friedy Mfg. Co., Inc. | 2007-06-21 | 76 | 0 |
| K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | Hu-Friedy Mfg. Co., Inc. | 2006-02-01 | 79 | 0 |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSE | Hu-Friedy Mfg. Co., Inc. | 2001-07-27 | 25 | 0 |
| K953919 | DENTAL ULTRASONIC SCALER INSERTS | Hu-Friedy Mfg. Co., Inc. | 1995-10-07 | 47 | 0 |
| K912473 | ACCU-PLACER TM KIT | Hu-Friedy Mfg. Co., Inc. | 1991-07-24 | 50 | 0 |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | Hu-Friedy Mfg. Co., Inc. | 1984-11-08 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda