Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spident Co., Ltd. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
163 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261129 | OrthoFit | Spident Co., Ltd. | 2026-07-02 | 87 | 0 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 | 114 | 0 |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | 2025-05-30 | 115 | 0 |
| K242702 | VioSeal | Spident Co., Ltd. | 2024-11-07 | 59 | 0 |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1. | Spident Co., Ltd. | 2024-11-01 | 56 | 0 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 | 61 | 0 |
| K231523 | EsCom250 | Spident Co., Ltd. | 2023-07-24 | 59 | 0 |
| K214076 | EsCem | Spident Co., Ltd. | 2022-12-19 | 357 | 0 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 | 73 | 0 |
| K161774 | i-Sil | Spident Co., Ltd. | 2016-09-30 | 94 | 0 |
| K134022 | BASE IT | Spident Co., Ltd. | 2014-06-11 | 163 | 0 |
| K134021 | ESTEMP IMPLANT, ESTEMP CLEAR | Spident Co., Ltd. | 2014-06-10 | 162 | 0 |
| K120767 | ES BOND | Spident Co., Ltd. | 2012-05-24 | 71 | 0 |
| K120768 | ES FLOW | Spident Co., Ltd. | 2012-05-03 | 50 | 0 |
| K110428 | ESCOM 100 | Spident Co., Ltd. | 2011-02-25 | 11 | 0 |
| K100413 | TEMP IT | Spident Co., Ltd. | 2010-03-03 | 15 | 0 |
| K100290 | ESTEMP NE | Spident Co., Ltd. | 2010-02-17 | 15 | 0 |
| K092572 | CORE*IT DUAL | Spident Co., Ltd. | 2009-08-26 | 5 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda