Great Batch Medical: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Great Batch Medical” (first 2009, latest 2018), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 102 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 | 3 | 159 |
| 2013 | 1 | 81 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 15 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Great Batch Medical took a median 15 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 64 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 7 | 7 |
| DRC | Trocar | 2 | 2 |
| DRA | Catheter, Steerable | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 0 |
Review panels
- Cardiovascular (11)
Most recent Great Batch Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181855 | RadialSeal Introducer Kit | DYB | 2018-07-26 | 15 |
| K130559 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH | DYB | 2013-05-24 | 81 |
| K122832 | MOBICATH TRANSSEPTAL NEEDLE | DRC | 2012-12-19 | 93 |
| K112541 | Z FLEX-270TM STEERABLE SHEATH | DRA | 2012-02-07 | 159 |
| K110051 | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT | DYB | 2012-02-02 | 391 |
| K111644 | MOBICATH TRANSSEPTAL NEEDLE | DRC | 2011-10-03 | 112 |
| K101784 | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX | DYB | 2010-11-26 | 154 |
| K102540 | PTFE PORTABLE INTRODUCER | DYB | 2010-11-16 | 74 |
| K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER | DYB | 2010-03-15 | 152 |
| K093023 | PTFE PEELABLE INTRODUCER | DYB | 2009-10-29 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130012 | PMA | MYOPORE SUTURELESS MYOCARDIAL PACING LEAD | 2015-04-30 |
Recalls
openFDA lists no recalls under a recalling firm named Great Batch Medical.
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.
- Great Lakes Orthodontics, Ltd. (13 510(k)s)
- Great Basin Scientific, Inc. (4 510(k)s)
- Great Glove Sdn Bhd (4 510(k)s)
- Great Eastern Lumber Co., Inc. (2 510(k)s)
- Great Glove (China), Inc. (2 510(k)s)
- Great Glove (Thailand) Co. , Ltd. (2 510(k)s)
- Great Basin Corporation (1 510(k)s)
- Great Bay Medical Products, Inc. (1 510(k)s)
- Great Eco Glove Sdn. Bhd. (1 510(k)s)
- Great Field Industries Co., Ltd. (1 510(k)s)
- Great Future Works , Ltd. (1 510(k)s)
- Great Group Medical Co, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Great Batch Medical?
FDA lists 10 510(k) clearances under the applicant name “Great Batch Medical” (first 2009, latest 2018), plus 1 PMA decision, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Great Batch Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Great Batch Medical is 102 days.
Which FDA product codes appear under Great Batch Medical?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 7); DRC (Trocar, 2); DRA (Catheter, Steerable, 1).
Next steps
- See all 10 Great Batch Medical clearances with predicates and recalls
- Run predicate analysis for product code DYB, Great Batch Medical'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.