Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American I.V. Products, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
379 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | 2012-04-12 | 79 | 0 |
| K070232 | ECG CABLES, TRUNK AND PATIENT LEAD WIRES | American I.V. Products, Inc. | 2007-03-27 | 62 | 0 |
| K070342 | CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11 | American I.V. Products, Inc. | 2007-03-19 | 41 | 0 |
| K052544 | PULSE OXIMETER ADAPTER CABLES | American I.V. Products, Inc. | 2006-09-29 | 379 | 0 |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITOR | American I.V. Products, Inc. | 2004-09-14 | 210 | 0 |
| K040819 | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 A | American I.V. Products, Inc. | 2004-08-16 | 139 | 0 |
| K032789 | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPL | American I.V. Products, Inc. | 2003-10-09 | 31 | 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