Leica Microsystems (Schweiz) AG: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Leica Microsystems (Schweiz) AG” (first 2008, latest 2018), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 88 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 | 1 | 160 |
| 2018 | 1 | 88 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Leica Microsystems (Schweiz) AG took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZI | System, X-Ray, Angiographic | 3 | 3 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 1 | 0 |
Review panels
Most recent Leica Microsystems (Schweiz) AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181537 | GLOW800 | IZI | 2018-09-07 | 88 |
| K170239 | Leica FL560 | IZI | 2017-07-05 | 160 |
| K080612 | LEICA FL800 | IZI | 2008-05-09 | 66 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180024 | De Novo | Diagnostic Neurosurgical Microscope Filter | 2019-03-28 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-12-18.
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.
Device clinical trials
An industry sponsor named Leica Microsystems (Schweiz) AG is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07164040: Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use. (Recruiting, started 2026-01-20)
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.
- Leica Biosystems Imaging, Inc. (5 510(k)s)
- Leica, Inc. (3 510(k)s)
- Leica Biosystems Newcastle, Ltd. (3 510(k)s)
- Leica Biosystems Newcastle, Limited (3 510(k)s)
- Leica Microsystems, Inc. (2 510(k)s)
- Leica Biosystems Richmond (1 510(k)s)
- Leica Microscopy Systems , Ltd. (1 510(k)s)
- Leica Microsystems, Inc. O.I.D. (1 510(k)s)
- Leica Biosystems (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Leica Microsystems (Schweiz) AG?
FDA lists 3 510(k) clearances under the applicant name “Leica Microsystems (Schweiz) AG” (first 2008, latest 2018), plus 1 De Novo decision, across 2 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 Leica Microsystems (Schweiz) AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Leica Microsystems (Schweiz) AG is 88 days.
Which FDA product codes appear under Leica Microsystems (Schweiz) AG?
The most frequent FDA product codes under this applicant name are IZI (System, X-Ray, Angiographic, 3); QFX (Diagnostic Neurosurgical Microscope Filter, 1).
Next steps
- See all 3 Leica Microsystems (Schweiz) AG clearances with predicates and recalls
- Run predicate analysis for product code IZI, Leica Microsystems (Schweiz) AG'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.