American I.V. Products, Inc.
Harmans, MD, US
AMERICAN I.V. PRODUCTS, INC. appears in FDA device records in Harmans, MD. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for American I.V. Products, Inc. between 2003 and 2012. The busiest year on record is 2004, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | MRZ | Substantially Equivalent | |
| K070232 | ECG CABLES, TRUNK AND PATIENT LEAD WIRES | DSA | Substantially Equivalent | |
| K070342 | CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 | FLL | Substantially Equivalent | |
| K052544 | PULSE OXIMETER ADAPTER CABLES | DQA | Substantially Equivalent | |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | HFM | Substantially Equivalent | |
| K040819 | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 | HGM | Substantially Equivalent | |
| K032789 | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1121996 | 1121996 | AMERICAN I.V. PRODUCTS, INC. | 7485 SHIPLEY AVE., HARMANS, MD 21077 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRZAccessories, Pump, Infusion
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- FLLContinuous Measurement Thermometer
- EYJHolder, Ureteral Catheter
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- DQAOximeter
- FRNPump, Infusion
- HGMSystem, Monitoring, Perinatal
- HGLTransducer, Ultrasonic, Obstetric
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain