Alexander Mfg. Co.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Alexander Mfg. Co.” (first 1997, latest 1998), across 23 product codes in 7 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | 8 | 8 |
| DQA | Oximeter | 4 | 4 |
| DPS | Electrocardiograph | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| LDR | Controller, Infusion, Intravascular, Electronic | 2 | 2 |
| MSG | Ophthalmoscopes, Replacement Batteries, Hand-Held | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | 1 | 1 |
Plus 13 more product codes.
Review panels
- General Hospital (15)
- Cardiovascular (8)
- Anesthesiology (6)
- Obstetrics and Gynecology (3)
- Ophthalmic (3)
- General and Plastic Surgery (3)
- Gastroenterology and Urology (1)
Most recent Alexander Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982896 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9 | LDD | 1998-10-21 | 65 |
| K981776 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X | FRN | 1998-08-03 | 75 |
| K981728 | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 | BZQ | 1998-06-26 | 42 |
| K980224 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 | MOQ | 1998-04-02 | 70 |
| K974061 | RECHARGEABLE BATTERY PART NUMBER GL825-200 | DXN | 1998-01-16 | 81 |
| K973851 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 | FRN | 1998-01-05 | 89 |
| K973850 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | HFO | 1997-11-12 | 35 |
| K972746 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100 | DPS | 1997-10-21 | 90 |
| K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 | MRZ | 1997-10-20 | 87 |
| K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P | MRZ | 1997-10-20 | 87 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alexander Mfg. Co..
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 Alexander Mfg. Co. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via MOQ)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRZ)
- 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.
- Alexander Medical, Inc. (1 510(k)s)
- Alexander Thomas, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alexander Mfg. Co.?
FDA lists 39 510(k) clearances under the applicant name “Alexander Mfg. Co.” (first 1997, latest 1998), across 23 product codes in 7 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 Alexander Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alexander Mfg. Co. is 71 days.
Which FDA product codes appear under Alexander Mfg. Co.?
The most frequent FDA product codes under this applicant name are MRZ (Accessories, Pump, Infusion, 8); DQA (Oximeter, 4); DPS (Electrocardiograph, 2).
Next steps
- See all 39 Alexander Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code MRZ, Alexander Mfg. Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.