Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OAN — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
195 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244056 | DOC Band 3D | Cranial Technologies, Inc. | 2025-03-17 | 76 | 0 |
| K240466 | STARband 3D | Orthomerica Products, Inc. | 2024-03-15 | 28 | 0 |
| K211376 | STARband | Orthomerica Products, Inc. | 2021-08-17 | 105 | 0 |
| K203098 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2021-04-27 | 195 | 0 |
| K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018-03-01 | 44 | 0 |
| K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016-07-20 | 89 | 0 |
| K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015-09-18 | 63 | 0 |
| K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015-07-01 | 62 | 0 |
| K142141 | STARBAND, STARLIGHT | Orthomerica Products, Inc. | 2015-04-23 | 261 | 0 |
| K133250 | STARLIGHT | Orthomerica Products, Inc. | 2014-01-16 | 86 | 0 |
| K124023 | STARBAND | Orthomerica Products, Inc. | 2013-06-10 | 164 | 0 |
| K090587 | STARLIGHT | Orthomerica Products, Inc. | 2009-07-17 | 135 | 0 |
| K081787 | CAMLAB CRANIAL ORTHOSIS HELMET | Biosculptor Corporation | 2009-01-27 | 217 | 0 |
| K082950 | STARBAND | Orthomerica Products, Inc. | 2008-12-05 | 63 | 0 |
| K082945 | STARLIGHT | Orthomerica Products, Inc. | 2008-10-31 | 29 | 0 |
| K081994 | STARLIGHT | Orthomerica Products, Inc. | 2008-09-12 | 60 | 0 |
| K072862 | BOSTON-BAND CRANIAL REMODLING ORTHOSIS | Boston Brace Intl., Inc. | 2008-01-22 | 109 | 0 |
| K072566 | HANGER CRANIAL BAND | Hanger Prosthetics & Orthotics, Inc. | 2008-01-09 | 119 | 0 |
| K063098 | STATIC CRANIOPLASTY ORTHOSIS | Boston Brace Intl., Inc. | 2007-04-11 | 183 | 0 |
| K021918 | CLARREN HELMET (ORTHOMERICA) | Orthomerica Products, Inc. | 2002-07-25 | 44 | 0 |
| K021207 | STARLIGHT | Orthomerica Products, Inc. | 2002-07-09 | 84 | 0 |
| K014012 | DOC BAND | Cranial Technologies, Inc. | 2002-01-28 | 54 | 0 |
| K011350 | STARBAND CRANIAL ORTHOSIS | Orthomerica Products, Inc. | 2001-07-03 | 62 | 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