Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alto Development Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
383 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964621 | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP AC | Alto Development Corp. | 1996-12-20 | 32 | 0 |
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | Alto Development Corp. | 1994-01-07 | 227 | 0 |
| K931537 | A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT | Alto Development Corp. | 1993-09-07 | 162 | 0 |
| K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | Alto Development Corp. | 1993-05-17 | 104 | 0 |
| K914193 | A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT | Alto Development Corp. | 1992-10-05 | 383 | 0 |
| K915300 | A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES | Alto Development Corp. | 1992-02-18 | 89 | 0 |
| K884783 | RANEY CLIP | Alto Development Corp. | 1988-11-30 | 15 | 0 |
| K881413 | ELECTRO-CAUTERY SUCTION TUBE | Alto Development Corp. | 1988-04-21 | 17 | 2 |
| K831867 | PRESSURE MONITORING IV BOTTLE CAP | Alto Development Corp. | 1983-08-12 | 63 | 0 |
| K821518 | MYO/CLIP | Alto Development Corp. | 1982-07-08 | 48 | 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