International Medsurg Connection: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “International Medsurg Connection” (first 1997, latest 2011), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 128 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 | 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 5 | 5 |
| FMF | Syringe, Piston | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
| MMP | Cover, Barrier, Protective | 1 | 1 |
Review panels
Most recent International Medsurg Connection 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110882 | IMC INSULIN SYRINGE | FMF | 2011-08-18 | 141 |
| K110656 | IMC BLOOD COLLECTION NEEDLE | FMI | 2011-08-18 | 164 |
| K102584 | IMC HYPODERMIC NEEDLE | FMI | 2011-01-14 | 128 |
| K102969 | IMC PISTON SYRINGES | FMF | 2010-12-20 | 75 |
| K100991 | IMC SURGICAL DRAPE | KKX | 2010-10-05 | 179 |
| K100846 | IMC SURGICAL FACE MASK | FXX | 2010-08-16 | 144 |
| K100208 | IMC SURGICAL DRAPE | KKX | 2010-04-20 | 85 |
| K052169 | IMC SURGICAL DRAPES | KKX | 2005-11-17 | 100 |
| K042893 | UNDER BUTTOCKS DRAPE | KKX | 2005-03-11 | 143 |
| K023808 | IRRIGATION SETS | LJH | 2003-03-10 | 116 |
3 earlier clearances. See the full list in Caduvo.
Recalls
65 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-06-23.
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.
- International Technidyne Corp. (48 510(k)s)
- International Imaging Electronics (19 510(k)s)
- International Biomedical (17 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medical Products, Inc. (9 510(k)s)
- International Newtech Development, Inc. (8 510(k)s)
- International Enzymes, Inc. (7 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Medsurg Connection?
FDA lists 13 510(k) clearances under the applicant name “International Medsurg Connection” (first 1997, latest 2011), across 6 product codes in 2 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 International Medsurg Connection?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Medsurg Connection is 128 days.
Which FDA product codes appear under International Medsurg Connection?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 5); FMF (Syringe, Piston, 3); FMI (Needle, Hypodermic, Single Lumen, 2).
Next steps
- See all 13 International Medsurg Connection clearances with predicates and recalls
- Run predicate analysis for product code KKX, International Medsurg Connection'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.