Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultimed, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
114 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100812 | ULTICARE DISPOSABLE PEN NEEDLES | Ultimed, Inc. | 2010-06-03 | 72 | 0 |
| K080600 | ULTIMED ULTICARE SAFETY SYRINGE | Ultimed, Inc. | 2008-06-25 | 114 | 0 |
| K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTA | Ultimed, Inc. | 2008-06-03 | 11 | 0 |
| K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES | Ultimed, Inc. | 2006-11-29 | 79 | 1 |
| K050464 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 | Ultimed, Inc. | 2005-05-11 | 77 | 0 |
| K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | Ultimed, Inc. | 2003-12-30 | 25 | 0 |
| K021983 | ULTI GUARD HOME INSULIN SYRINGE CONTAINER | Ultimed, Inc. | 2002-09-16 | 90 | 0 |
| K994230 | ULTICARE DISPOSABLE SYRINGE | Ultimed, Inc. | 2000-03-24 | 99 | 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