Intl. Management Services, Inc.: FDA clearances and approvals
Intl. Management Services, Inc. has 4 FDA 510(k) clearances (first 1983, latest 1987), plus 1 PMA decision, across 5 product codes in 4 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 |
|---|---|---|---|
| FOH | Mattress, Water, Temperature Regulated | 1 | 1 |
| FSE | Table, Operating-Room, Manual | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| IQA | System, Environmental Control, Powered | 1 | 1 |
| KGP | 1 | 0 |
Review panels
Most recent Intl. Management Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873612 | IMSI, VITAL CALL | IQA | 1987-11-23 | 76 |
| K872876 | IMSI/EASY FLOAT MATTRESS | FOH | 1987-10-13 | 84 |
| K843370 | IMSI/METRIPOND GRIPPER PLATE | HRS | 1985-01-23 | 148 |
| K830339 | IMSI/METRIPOND HAND OPERATING TABLE | FSE | 1983-04-12 | 70 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880089 | PMA | AGENASORB | 1990-09-13 |
Recalls
openFDA lists no recalls under a recalling firm named Intl. Management Services, 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 Intl. Management Services, Inc. have?
Intl. Management Services, Inc. has 4 FDA 510(k) clearances (first 1983, latest 1987), plus 1 PMA decision, across 5 product codes in 4 review panels.
How long does FDA take to clear Intl. Management Services, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Intl. Management Services, Inc.'s cleared 510(k)s is 80 days.
What devices does Intl. Management Services, Inc. make?
Its most frequent FDA product codes are FOH (Mattress, Water, Temperature Regulated, 1); FSE (Table, Operating-Room, Manual, 1); HRS (Plate, Fixation, Bone, 1).
Has Intl. Management Services, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Intl. Management Services, Inc. Related entities may recall under other names.
Next steps
- See all 4 Intl. Management Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOH, Intl. Management Services, 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.