Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NZP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223669 | SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC | 2023-06-12 | 187 | 0 |
| K170505 | SecurePortIV Catheter Securement Adhesive | Adhezion Biomedical, LLC | 2017-09-29 | 220 | 0 |
| K083354 | FLORASEAL, MODEL FS350D | Adhezion Biomedical | 2009-07-20 | 249 | 0 |
| K052870 | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 | Kimberly-Clark Corp. | 2006-09-29 | 353 | 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