Alm Surgical Equipment, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alm Surgical Equipment, Inc.” (first 1988, latest 1998), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | 4 | 4 |
| FSQ | Light, Surgical, Instrument | 2 | 2 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
| FTD | Lamp, Surgical | 1 | 1 |
| FWX | Table, Operating-Room, Mechanical | 1 | 1 |
Review panels
Most recent Alm Surgical Equipment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982063 | ALM PRISMALIX (PRX) SURGICAL LIGHT | FSY | 1998-09-22 | 102 |
| K961886 | DRAGER GEMINA WALL-MOUNTED WORKPLACE | FQO | 1996-07-30 | 76 |
| K961742 | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM | FQO | 1996-07-26 | 81 |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | FFS | 1994-11-04 | 17 |
| K942043 | DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E | FQO | 1994-07-13 | 76 |
| K922409 | ALM ILLUMINATOR SERIES LIGHT SYSTEM | FSQ | 1993-01-12 | 236 |
| K921297 | DRAGER DVE 4000 SERIES SYSTEM | FQO | 1992-11-27 | 255 |
| K921848 | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | FSQ | 1992-10-01 | 167 |
| K884019 | ALM OPERATING TABLES | FWX | 1988-10-13 | 21 |
| K882613 | ALM SURGICAL LAMPS | FTD | 1988-07-18 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Alm Surgical Equipment, 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 Alm Surgical Equipment, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Alm Surgical Equipment, Inc.” (first 1988, latest 1998), across 6 product codes in 2 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 Alm Surgical Equipment, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alm Surgical Equipment, Inc. is 78 days.
Which FDA product codes appear under Alm Surgical Equipment, Inc.?
The most frequent FDA product codes under this applicant name are FQO (Table, Operating-Room, Ac-Powered, 4); FSQ (Light, Surgical, Instrument, 2); FFS (Image, Illumination, Fiberoptic, For Endoscope, 1).
Next steps
- See all 10 Alm Surgical Equipment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FQO, Alm Surgical Equipment, 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.