510(k) · Cleared
ClearedShanghai Ganghai Model Giko 1400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Gangkai Purifying Products Co., Ltd. · MSH Respirator, Surgical
Cleared on Dec 8, 2006 as substantially equivalent to K050193 (Louis M. Gerson Co., Inc., 2005) after a 32-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Dec 8, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050193 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK050193 Gerson 2130/31 Type N95 Niosh Certified Surgical RespiratorLouis M. Gerson Co., Inc. · 2005
- This deviceK063334 Shanghai Ganghai Model Giko 1400Shanghai Gangkai Purifying Products Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050193 | Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator | Louis M. Gerson Co., Inc. | 2005 | — |
| 0 (this device) | K063334 | Shanghai Ganghai Model Giko 1400 | Shanghai Gangkai Purifying Products Co., Ltd. | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSH device
- #1 K233022 Halyard Fluidshield 3 N95 Particulate Filter…score 6.7 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050193 | Gerson 2130/31 Type N95 Niosh Certified Surgical RespiratorSummary page 1…lency: The Model GIKO 1400 Heathcare Particulate Respirator and Surgical Mask is found to be substantially equivalent to the Gerson Model 2130 Type N95 Mask. (510(K) No. K050193. Both products have been tested and approved by NIOSH as N-95 respirators. 2 ===… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MSH
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSH
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSH
10in 2025
MAUDE reports naming product code MSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 78 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 4 | 60 | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
This device also meets CDC Guidelines for TB Exposure Control.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K063334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063334: Shanghai Ganghai Model Giko 1400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063334
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026