American I.V. Products, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “American I.V. Products, Inc.” (first 2003, latest 2012), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 79 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 79 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| MRZ | Accessories, Pump, Infusion | 1 | 1 |
Review panels
Most recent American I.V. Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | MRZ | 2012-04-12 | 79 |
| K070232 | ECG CABLES, TRUNK AND PATIENT LEAD WIRES | DSA | 2007-03-27 | 62 |
| K070342 | CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 | FLL | 2007-03-19 | 41 |
| K052544 | PULSE OXIMETER ADAPTER CABLES | DQA | 2006-09-29 | 379 |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | HFM | 2004-09-14 | 210 |
| K040819 | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 | HGM | 2004-08-16 | 139 |
| K032789 | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 | FRN | 2003-10-09 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named American I.V. Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under American I.V. Products, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American I.V. Products, Inc.?
FDA lists 7 510(k) clearances under the applicant name “American I.V. Products, Inc.” (first 2003, latest 2012), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American I.V. Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American I.V. Products, Inc. is 79 days.
Which FDA product codes appear under American I.V. Products, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 1); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 7 American I.V. Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, American I.V. Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.