510(k) Report

FDA applicant

Harvest Technologies, Corp.

Plymouth, MA9 decisions1999–20125 recalls

FDA records 9 decisions for Harvest Technologies, Corp. (Plymouth, MA) from 1999 to 2012: 9 510(k) clearances. Most are in product codes JQC (Centrifuges (Micro, Ultra, Refrigerated) For…) and FMF (Syringe, Piston). Its devices cite 8 predicates, 2 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Harvest Technologies, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Harvest Technologies, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2017

2013: 12016: 12017: 3
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Harvest Technologies, Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Harvest Technologies, Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Harvest”

FDA records each applicant name separately; these may or may not be the same firm.