Zeiss Humphrey System: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Zeiss Humphrey System” (first 1979, latest 1994), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ZEISS Medical Technology, based on public ownership records.
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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HKO | Refractometer, Ophthalmic | 1 | 1 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 | 1 |
| HLQ | Keratoscope, Ac-Powered | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Ophthalmic (6)
- Radiology (2)
- General and Plastic Surgery (1)
Most recent Zeiss Humphrey System 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942439 | ZEISS OPMILAS 144 SURGICAL LASERS | GEX | 1994-07-01 | 112 |
| K923211 | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE | IYO | 1993-11-08 | 495 |
| K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED | ITX | 1992-12-10 | 196 |
| K852639 | HUMPHREY FIELD ANALYZER MODEL 630 | HPT | 1985-09-18 | 90 |
| K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 | HKI | 1985-08-12 | 53 |
| K821940 | THE HUMPHREY FIELD ANALYZER MODEL 610 | HPT | 1982-07-28 | 29 |
| K802029 | OBJECTIVE REFRACTOR | HKO | 1980-11-12 | 83 |
| K781994 | AUTOKERATOMETER, INSTRUMENT | HLQ | 1979-02-12 | 75 |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | HLM | 1979-01-26 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Zeiss Humphrey System.
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.
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.
- ZEISS (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zeiss Humphrey System?
FDA lists 9 510(k) clearances under the applicant name “Zeiss Humphrey System” (first 1979, latest 1994), across 8 product codes in 3 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 Zeiss Humphrey System?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zeiss Humphrey System is 83 days.
Which FDA product codes appear under Zeiss Humphrey System?
The most frequent FDA product codes under this applicant name are HPT (Perimeter, Automatic, Ac-Powered, 2); GEX (Powered Laser Surgical Instrument, 1); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Next steps
- See all 9 Zeiss Humphrey System clearances with predicates and recalls
- Run predicate analysis for product code HPT, Zeiss Humphrey System'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.