Harvest Technologies, Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Harvest Technologies, Corp.” (first 1999, latest 2012), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Terumo, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 171 |
| 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| MUU | System, Suction, Lipoplasty | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- General Hospital (3)
- Cardiovascular (1)
- Dental (1)
- General and Plastic Surgery (1)
Most recent Harvest Technologies, Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM | MUU | 2012-09-21 | 171 |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | JQC | 2010-12-06 | 21 |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | JQC | 2006-01-04 | 78 |
| K043261 | HARVEST GRAFT DELIVERY SYRINGE | FMF | 2005-03-11 | 107 |
| K020252 | SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 | FMF | 2002-04-05 | 71 |
| K011032 | SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA | LYC | 2001-07-03 | 89 |
| K000456 | HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2 | FMF | 2000-06-01 | 111 |
| K991430 | SMARTPREP CENTRIFUGE SYSTEM | JQC | 1999-05-28 | 32 |
| K983022 | SMARTCELL PROCESSING SYSTEM | CAC | 1999-04-02 | 214 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-09-11.
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.
Device clinical trials
An industry sponsor named Harvest Technologies, Corp. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01245335: Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI) (Completed, started 2011-05)
- NCT01299324: Retrograde Delivery of BMAC (Bone Marrow Aspirate Concentrate) for Congestive Heart Failure (Completed, started 2011-02)
- NCT00595257: Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI (Completed, started 2007-12)
- NCT00498069: Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI) (Completed, started 2007-11)
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.
- Harvest Dental Products, LLC (5 510(k)s)
- Harvest Intl. of America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Harvest Technologies, Corp.?
FDA lists 9 510(k) clearances under the applicant name “Harvest Technologies, Corp.” (first 1999, latest 2012), across 5 product codes in 5 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 Harvest Technologies, Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harvest Technologies, Corp. is 89 days.
Which FDA product codes appear under Harvest Technologies, Corp.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 3); JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 3); CAC (Apparatus, Autotransfusion, 1).
Next steps
- See all 9 Harvest Technologies, Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Harvest Technologies, Corp.'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.