Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tianjin Huahong Technology Co., Ltd. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
188 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | 2026-08-05 | 142 | 0 |
| K262211 | Lancet | Tianjin Huahong Technology Co., Ltd. | 2026-07-22 | 22 | 0 |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 | 68 | 0 |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 | 188 | 0 |
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 | 15 | 0 |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 | 24 | 0 |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 | 25 | 0 |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 | 14 | 0 |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 | 57 | 0 |
| K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII- | Tianjin Huahong Technology Co., Ltd. | 2022-07-06 | 138 | 0 |
| K221176 | Insulin Pen Needle | Tianjin Huahong Technology Co., Ltd. | 2022-07-01 | 67 | 0 |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI | Tianjin Huahong Technology Co., Ltd. | 2022-05-19 | 99 | 0 |
| K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | 2022-05-17 | 97 | 0 |
| K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safe | Tianjin Huahong Technology Co., Ltd. | 2021-11-12 | 452 | 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