Amco International Manufacturing & Design, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Amco International Manufacturing & Design, Inc.” (first 2007, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 102 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 | 0 | — |
| 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 4 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Amco International Manufacturing & Design, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A | MKJ | 2009-08-07 | 72 |
| K082861 | AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 | MKJ | 2008-11-25 | 57 |
| K073716 | LIFE+CEL OR LIFECEL BATTERY | MKJ | 2008-04-11 | 102 |
| K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | MKJ | 2008-01-24 | 132 |
| K071164 | LIFE+CEL BATTERY | MHX | 2007-12-07 | 225 |
Recalls
openFDA lists no recalls under a recalling firm named Amco International Manufacturing & Design, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Amco International Manufacturing & Design, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Amco International Manufacturing & Design, Inc.” (first 2007, latest 2009), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Amco International Manufacturing & Design, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amco International Manufacturing & Design, Inc. is 102 days.
Which FDA product codes appear under Amco International Manufacturing & Design, Inc.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 4); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 1).
Next steps
- See all 5 Amco International Manufacturing & Design, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Amco International Manufacturing & Design, 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.