Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Medical Products, Inc. · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
91 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922290 | SINGLE-STEP PREGNANCY, HCG TEST | American Medical Products, Inc. | 1992-07-09 | 55 | 0 |
| K862221 | E-Z CLEAN | American Medical Products, Inc. | 1986-09-12 | 93 | 0 |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | American Medical Products, Inc. | 1986-04-17 | 15 | 0 |
| K830881 | AMPERCIDE DISINFECTANT ACCESSORY TO - | American Medical Products, Inc. | 1983-06-02 | 76 | 0 |
| K823827 | AMP 80/2 OUTFLOW MONITOR MODIFICATION | American Medical Products, Inc. | 1983-03-17 | 87 | 0 |
| K822543 | CAPD SAFE LOCK TRANSFER SET | American Medical Products, Inc. | 1982-10-13 | 51 | 0 |
| K822544 | SAFE LOCK SEALING CAP L | American Medical Products, Inc. | 1982-10-13 | 51 | 0 |
| K822545 | CCPD CYCLER SET W/5 PRONGED CONNECTOR | American Medical Products, Inc. | 1982-10-13 | 51 | 0 |
| K822546 | SAFE LOCK SEALING CAPS | American Medical Products, Inc. | 1982-10-13 | 50 | 0 |
| K822548 | SAFE LOCK CATHETER S-3 | American Medical Products, Inc. | 1982-10-13 | 50 | 0 |
| K822549 | CCPD CYCLER SET W/5 PRONGED SAFE LOCK | American Medical Products, Inc. | 1982-10-13 | 50 | 0 |
| K822550 | SAFE LOCK TITANIUM ADAPTER SET | American Medical Products, Inc. | 1982-10-13 | 50 | 1 |
| K822551 | AMP CAPD UNISPIKE AMINISTRATION SET | American Medical Products, Inc. | 1982-10-13 | 50 | 0 |
| K822547 | CAPD BELT | American Medical Products, Inc. | 1982-09-09 | 16 | 0 |
| K813069 | PERITONEAL DIALYSIS CYCLER SET | American Medical Products, Inc. | 1981-11-16 | 17 | 0 |
| K811986 | THE AMP 80/2 PEDIATRIC CYCLER SYSTEM | American Medical Products, Inc. | 1981-08-31 | 49 | 0 |
| K811917 | I.V. ADMIN. SETS FOR THE AMP MARK IV PMP | American Medical Products, Inc. | 1981-07-23 | 21 | 0 |
| K811918 | AMP MARK IV INFUSION PUMP | American Medical Products, Inc. | 1981-07-20 | 18 | 0 |
| K810840 | AMP PERITONEAL DIALYSIS PREP KIT | American Medical Products, Inc. | 1981-04-29 | 33 | 0 |
| K810670 | CCPD CYCLER SET | American Medical Products, Inc. | 1981-03-24 | 12 | 0 |
| K810671 | CCPD 3 LITER DRAINAGE SET | American Medical Products, Inc. | 1981-03-24 | 12 | 0 |
| K810236 | MIROMED PERITONEAL DIALYSIS CATHETER | American Medical Products, Inc. | 1981-03-13 | 45 | 0 |
| K802600 | AMP PORTABLE PATIENT PRESSURE MONITOR | American Medical Products, Inc. | 1980-11-12 | 22 | 0 |
| K801220 | PERITONEAL DIALYSIS CYCLER SET W/PUMP | American Medical Products, Inc. | 1980-08-12 | 82 | 0 |
| K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | American Medical Products, Inc. | 1980-07-21 | 139 | 0 |
| K792646 | AMP DIRECT VASCULAR MONITORING SYSTEM | American Medical Products, Inc. | 1980-02-11 | 52 | 0 |
| K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS | American Medical Products, Inc. | 1979-11-16 | 91 | 0 |
| K791722 | DISPOSABLE PERITONEAL DIALYSIS EXTENSION | American Medical Products, Inc. | 1979-11-16 | 78 | 0 |
| K790091 | AMP AUTOMATIC CYCLER STAND | American Medical Products, Inc. | 1979-02-16 | 31 | 0 |
| K780957 | SET, ADMINISTRATION, MANUAL, DIALYSIS | American Medical Products, Inc. | 1978-07-06 | 24 | 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