Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KIP — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
70 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870482 | (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 | Sigma Chemical Co. | 1987-03-30 | 55 | 0 |
| K870491 | KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 | Sigma Chemical Co. | 1987-03-30 | 55 | 0 |
| K870486 | EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 | Sigma Chemical Co. | 1987-03-30 | 55 | 0 |
| K870484 | HANKS' BALANCED SALTS (HBSS) NO. H1387 | Sigma Chemical Co. | 1987-03-30 | 55 | 0 |
| K860784 | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | Tissue Culture Innovations | 1986-03-12 | 9 | 0 |
| K844877 | HEPES BUFFER IM IN NORMAL SALINE | Hazleton Research Products, Inc. | 1985-02-25 | 70 | 0 |
| K844878 | TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG | Hazleton Research Products, Inc. | 1985-02-25 | 70 | 0 |
| K842723 | SALINE, 1.3% W/O PRESERVATIVE | E K Ind., Inc. | 1984-08-03 | 21 | 0 |
| K842725 | SALINE, 0.85%W/PRESERVATIVE | E K Ind., Inc. | 1984-08-03 | 21 | 0 |
| K842724 | SALINE 0.85% W/O PRESERVATIVE | E K Ind., Inc. | 1984-08-03 | 21 | 0 |
| K820928 | EBS POWDER | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820923 | DULBECCO'S PBS POWDER | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K820927 | HBS POWDER | Dutchland Laboratories, Inc. | 1982-04-21 | 20 | 0 |
| K810779 | EARLE'S BALANCED SALTS SOULTION | Dutchland Laboratories, Inc. | 1981-05-13 | 51 | 0 |
| K810777 | HANKS' BALANCED SALTS SOLUTION (MODIF.) | Dutchland Laboratories, Inc. | 1981-05-08 | 46 | 0 |
| K810766 | HANKS' BALANCED SALT SOLUTION W/O CA-MG | Dutchland Laboratories, Inc. | 1981-05-08 | 46 | 0 |
| K781391 | PBS FOR FA (46-991-49) | Flow Laboratories, Inc. | 1978-08-21 | 11 | 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