Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FIH · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
193 daysmedian FDA review time
692 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932055 | PERCUPUMP II | E-Z-Em, Inc. | 1995-03-21 | 692 | 0 |
| K931113 | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | Pharmacia Deltec, Inc. | 1994-04-28 | 420 | 0 |
| K935461 | VECTOR AMBULATORY DRUG DELIVERY SYSTEM | Infusion Technology Intl. | 1994-04-28 | 167 | 0 |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | L H M Ent., Inc. | 1990-02-15 | 17 | 0 |
| K881707 | INTROCULAR FLUID INJECTOR | B&B Medical Assoc., Inc. | 1988-10-21 | 193 | 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