Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Dimensions IN Medicine, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
83 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION | New Dimensions IN Medicine, Inc. | 1992-04-21 | 67 | 0 |
| K832145 | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE | New Dimensions IN Medicine, Inc. | 1983-07-19 | 14 | 0 |
| K822077 | RESPIRATION MONITOR TYPE MR-10 | New Dimensions IN Medicine, Inc. | 1982-10-06 | 83 | 0 |
| K780631 | NDM INFANT ECG PACKPAD | New Dimensions IN Medicine, Inc. | 1978-05-03 | 16 | 0 |
| K780405 | INFANT ELECTROSURGICAL GROUNDING PAD | New Dimensions IN Medicine, Inc. | 1978-04-05 | 23 | 0 |
| K771749 | AMALGAM DISPENSER | New Dimensions IN Medicine, Inc. | 1977-09-28 | 13 | 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