Jain Surgical Equipment, Inc.: FDA clearances and approvals
Jain Surgical Equipment, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1992), across 4 product codes in 2 review panels. Median 510(k) review time: 80 days.
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 |
|---|---|---|---|
| MMK | Container, Sharps | 2 | 2 |
| GCZ | Retainer, Surgical | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 | 1 |
Review panels
Most recent Jain Surgical Equipment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913896 | JAIN BLOOD SHIELD | JOL | 1992-03-06 | 189 |
| K911077 | JAIN SUTURE PACKAGE COUNTER | MMK | 1991-05-31 | 81 |
| K911076 | JAIN QUICK COUNT | MMK | 1991-05-30 | 80 |
| K905105 | JAIN SUTURE/VESIBAND ORGANIZER | MDM | 1991-01-31 | 79 |
| K904536 | JAIN GRAFT ASSIST | GCZ | 1990-11-29 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Jain Surgical Equipment, Inc..
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 Jain Surgical Equipment, Inc. have?
Jain Surgical Equipment, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1992), across 4 product codes in 2 review panels.
How long does FDA take to clear Jain Surgical Equipment, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Jain Surgical Equipment, Inc.'s cleared 510(k)s is 80 days.
What devices does Jain Surgical Equipment, Inc. make?
Its most frequent FDA product codes are MMK (Container, Sharps, 2); GCZ (Retainer, Surgical, 1); JOL (Catheter And Tip, Suction, 1).
Has Jain Surgical Equipment, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jain Surgical Equipment, Inc. Related entities may recall under other names.
Next steps
- See all 5 Jain Surgical Equipment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MMK, Jain Surgical Equipment, Inc.'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.