Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Creative Industry Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
218 daysmedian FDA review time
301 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2021-01-25 | 237 | 0 |
| K192343 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2019-12-31 | 125 | 0 |
| K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. | 2018-11-13 | 424 | 0 |
| K170047 | All-in-One Health Monitor, PC-303 | Shenzhen Creative Industry Co., Ltd. | 2017-09-09 | 247 | 0 |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60 | Shenzhen Creative Industry Co., Ltd. | 2015-06-03 | 138 | 0 |
| K123711 | PATIENT MONITOR | Shenzhen Creative Industry Co., Ltd. | 2013-10-01 | 301 | 0 |
| K120502 | PC-60NW FINGERTIP OXIMETER | Shenzhen Creative Industry Co., Ltd. | 2012-12-07 | 290 | 0 |
| K093016 | VITAL SIGNS MONITOR | Shenzhen Creative Industry Co., Ltd. | 2010-03-30 | 182 | 0 |
| K082055 | MODEL PC-860 FETAL DOPPLER | Shenzhen Creative Industry Co., Ltd. | 2009-02-06 | 200 | 0 |
| K073152 | PC-180 / PRINCE 180 EASY ECG MONITOR | Shenzhen Creative Industry Co., Ltd. | 2008-01-10 | 63 | 0 |
| K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | Shenzhen Creative Industry Co., Ltd. | 2007-07-13 | 218 | 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