Mettler Electronics Corp.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under 2 spellings of the applicant name “Mettler Electronics Corp.” (first 1985, latest 2024), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 98 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 | 1 | 259 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 291 |
| 2024 | 1 | 99 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mettler Electronics Corp. took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 13 | 13 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 7 | 7 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 6 | 6 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IKK | System, Isokinetic Testing And Evaluation | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Physical Medicine (31)
- Neurology (2)
- General Hospital (1)
Most recent Mettler Electronics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233926 | accufit | IPF | 2024-03-21 | 99 |
| K223802 | accufit | IPF | 2023-10-06 | 291 |
| K113017 | SYS*STIM 240 | IPF | 2012-06-26 | 259 |
| K111482 | SONICATOR PLUS 920 | IMG | 2011-08-25 | 90 |
| K091540 | MTD 4000 | ITH | 2009-10-08 | 135 |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | IMG | 2007-08-01 | 99 |
| K053546 | SONICATOR 740, MODEL ME 740 | IMI | 2006-05-04 | 135 |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | ILY | 2005-05-06 | 129 |
| K042554 | AUTO THERM 390, MODEL ME 390 | IMJ | 2004-10-08 | 18 |
| K031017 | SYS*STIM 208 AND 208A | IPF | 2003-05-30 | 60 |
24 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-04-14.
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 Mettler Electronics Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Mettler Electronics Corp. (32)
- Mettler Electronics Corporation (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mettler Electronics Corp.?
FDA lists 34 510(k) clearances under 2 spellings of the applicant name “Mettler Electronics Corp.” (first 1985, latest 2024), across 10 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 Mettler Electronics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mettler Electronics Corp. is 98 days.
Which FDA product codes appear under Mettler Electronics Corp.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 13); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 7); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 6).
Next steps
- See all 34 Mettler Electronics Corp. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Mettler Electronics Corp.'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.