Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
C.T.M. Homecare Product, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
78 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110395 | C.T.M. MOBILITY SCOOTER - MODEL HS 118 | C.T.M. Homecare Product, Inc. | 2011-04-22 | 70 | 0 |
| K110567 | C.T.M. MOBILITY SCOOTER HS515(3W) | C.T.M. Homecare Product, Inc. | 2011-04-22 | 53 | 0 |
| K090735 | C.T.M. MOBILITY SCOOTER, HS-528 | C.T.M. Homecare Product, Inc. | 2009-07-06 | 109 | 1 |
| K091418 | C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION | C.T.M. Homecare Product, Inc. | 2009-07-06 | 54 | 0 |
| K073686 | C.T.M. POWER CHAIR, MODEL HS-1500 | C.T.M. Homecare Product, Inc. | 2008-02-27 | 61 | 0 |
| K070602 | C.T.M. MOBILITY SCOOTER# HS-265 | C.T.M. Homecare Product, Inc. | 2007-04-02 | 28 | 0 |
| K070603 | C.T.M. MOBILITTY SCOOTER # HS-295 | C.T.M. Homecare Product, Inc. | 2007-03-20 | 15 | 0 |
| K070025 | C.T.M. MOBILITY SCOOTER, MODEL HS-310 | C.T.M. Homecare Product, Inc. | 2007-02-01 | 29 | 0 |
| K040020 | C.T.M. POWER CHAIR, MODEL HS-1000 | C.T.M. Homecare Product, Inc. | 2004-02-18 | 43 | 0 |
| K032919 | C.T.M. MOBILITY SCOOTER, MODEL HS-250 | C.T.M. Homecare Product, Inc. | 2003-10-15 | 23 | 0 |
| K032918 | C.T.M. MOBILITY SCOOTER, MODEL HS-235 | C.T.M. Homecare Product, Inc. | 2003-10-06 | 14 | 0 |
| K031272 | C.T.M. MOBILITY SCOOTER, MODEL HS-120 | C.T.M. Homecare Product, Inc. | 2003-05-20 | 28 | 0 |
| K030387 | C.T.M. MOBILITY SCOOTER, MODEL HS-890 | C.T.M. Homecare Product, Inc. | 2003-03-11 | 34 | 0 |
| K021617 | C.T.M. POWER CHAIR, MODEL HS-2800 | C.T.M. Homecare Product, Inc. | 2002-08-02 | 78 | 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