Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skytron, Div. the Kmw Group, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
216 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 2007-07-06 | 15 | 4 |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | Skytron, Div. the Kmw Group, Inc. | 2002-11-13 | 183 | 0 |
| K002463 | STELLAR | Skytron, Div. the Kmw Group, Inc. | 2000-11-08 | 90 | 0 |
| K992090 | MILLENNIUM GOLD | Skytron, Div. the Kmw Group, Inc. | 1999-09-08 | 79 | 0 |
| K950192 | SKYTRON SKYBOOM SERIES | Skytron, Div. the Kmw Group, Inc. | 1995-04-03 | 75 | 3 |
| K940616 | SKYTRON ELITE 3500 TABLE | Skytron, Div. the Kmw Group, Inc. | 1994-06-13 | 119 | 0 |
| K933564 | SKYTRON EXAM LIGHT | Skytron, Div. the Kmw Group, Inc. | 1994-02-10 | 203 | 0 |
| K926045 | SKYTRON LIFE ISLAND 21 | Skytron, Div. the Kmw Group, Inc. | 1993-07-27 | 238 | 0 |
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 1992-02-20 | 87 | 11 |
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | Skytron, Div. the Kmw Group, Inc. | 1990-09-04 | 216 | 0 |
| K900211 | SKYTRON UNIVERSE SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 1990-03-19 | 61 | 0 |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | Skytron, Div. the Kmw Group, Inc. | 1990-02-20 | 29 | 0 |
| K873478 | SKYTRON MODEL 130 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | 1987-09-24 | 31 | 0 |
| K870045 | SKYTRON MODEL 610-2 | Skytron, Div. the Kmw Group, Inc. | 1987-02-04 | 30 | 0 |
| K853480 | SKYTRON ELITE 6000 & 6001 SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | 1985-09-12 | 23 | 0 |
| K853479 | SKYTRON ELITE 300 SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-09-05 | 16 | 0 |
| K851830 | SKYTRON ELITE 7000 MICRO-SURGERY TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-05-17 | 21 | 0 |
| K851829 | SKYTRON ELITE 3100 SURGICAL TABLE | Skytron, Div. the Kmw Group, Inc. | 1985-05-17 | 21 | 0 |
| K811311 | SKYTRON ELITE SURGICAL TABLES | Skytron, Div. the Kmw Group, Inc. | 1981-06-02 | 22 | 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