Research Instruments , Ltd.: FDA clearances and approvals
Research Instruments , Ltd. has 7 FDA 510(k) clearances (first 1999, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time: 264 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 326 |
| 2013 | 0 | — |
| 2014 | 1 | 205 |
| 2015 | 1 | 264 |
| 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 |
|---|---|---|---|
| MRX | System, Assisted Reproduction Laser | 3 | 3 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 2 | 2 |
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 1 | 1 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Research Instruments , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141434 | SATURN 5 LASER | MRX | 2015-02-18 | 264 |
| K133257 | BIOPSY PIPETTES | MQH | 2014-05-16 | 205 |
| K112413 | RI MSC (MIGRATION SEDIMENTATION CHAMBER) | MQK | 2012-07-13 | 326 |
| K083208 | SATURN ACTIVE LASER SYSTEM | MRX | 2009-08-25 | 298 |
| K060764 | SATURN 3 LASER SYSTEM | MRX | 2007-03-12 | 356 |
| K003142 | MICROMANIPULATOR | MQJ | 2000-11-22 | 43 |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | MQH | 1999-08-05 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Research Instruments , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Research Instruments , Ltd. have?
Research Instruments , Ltd. has 7 FDA 510(k) clearances (first 1999, latest 2015), across 4 product codes in 1 review panel.
How long does FDA take to clear Research Instruments , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Research Instruments , Ltd.'s cleared 510(k)s is 264 days.
What devices does Research Instruments , Ltd. make?
Its most frequent FDA product codes are MRX (System, Assisted Reproduction Laser, 3); MQH (Microtools, Assisted Reproduction (Pipettes), 2); MQJ (Micromanipulators And Microinjectors, Assisted Reproduction, 1).
Has Research Instruments , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Research Instruments , Ltd. Related entities may recall under other names.
Next steps
- See all 7 Research Instruments , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MRX, Research Instruments , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.