Exact Medical Manufacturing, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Exact Medical Manufacturing, Inc.” (first 2010, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 | 158 |
| 2013 | 1 | 227 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 50 |
| 2022 | 0 | — |
| 2023 | 1 | 270 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Exact Medical Manufacturing, Inc. took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 4 | 4 |
| FYA | Gown, Surgical | 3 | 3 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
Review panels
- General Hospital (7)
- Radiology (2)
Most recent Exact Medical Manufacturing, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222460 | Intraoperative Ultrasound Probe Cover | ITX | 2023-05-12 | 270 |
| K211969 | EMM Ultrasonic Transducer Cover | ITX | 2021-08-13 | 50 |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | KKX | 2013-02-14 | 227 |
| K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | FYA | 2012-06-12 | 158 |
| K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | FYA | 2011-08-26 | 85 |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | KKX | 2010-10-04 | 118 |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | 2010-09-20 | 96 |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | KKX | 2010-09-20 | 96 |
| K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | FYA | 2010-09-03 | 87 |
Recalls
18 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-04-29.
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.
- Exact Imaging, Inc. (4 510(k)s)
- Exact Science, Inc. (1 510(k)s)
- Exact Supplies , Ltd. (1 510(k)s)
- Exact Sciences Corporation (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Exact Medical Manufacturing, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Exact Medical Manufacturing, Inc.” (first 2010, latest 2023), across 3 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 Exact Medical Manufacturing, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exact Medical Manufacturing, Inc. is 96 days.
Which FDA product codes appear under Exact Medical Manufacturing, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 4); FYA (Gown, Surgical, 3); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 9 Exact Medical Manufacturing, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Exact Medical Manufacturing, Inc.'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.