Skytron, Div. the Kmw Group, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Skytron, Div. the Kmw Group, Inc.” (first 1981, latest 2007), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 61 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | 6 | 6 |
| GDC | Table, Operating-Room, Electrical | 4 | 4 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| FWW | Table, Operating-Room, Pneumatic | 1 | 1 |
| FWY | Table, Operating-Room, Non-Electrical | 1 | 1 |
| GBC | Lamp, Surgical, Incandescent | 1 | 1 |
| HBN | Chair, Neurosurgical | 1 | 1 |
| INX | Bed, Air Fluidized | 1 | 1 |
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Skytron, Div. the Kmw Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | FSY | 2007-07-06 | 15 |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | FSY | 2002-11-13 | 183 |
| K002463 | STELLAR | FSY | 2000-11-08 | 90 |
| K992090 | MILLENNIUM GOLD | FSY | 1999-09-08 | 79 |
| K950192 | SKYTRON SKYBOOM SERIES | FQO | 1995-04-03 | 75 |
| K940616 | SKYTRON ELITE 3500 TABLE | GDC | 1994-06-13 | 119 |
| K933564 | SKYTRON EXAM LIGHT | KZF | 1994-02-10 | 203 |
| K926045 | SKYTRON LIFE ISLAND 21 | FNM | 1993-07-27 | 238 |
| K915285 | SKYTRON INFINITY SERIES SURGICAL LIGHTS | FSY | 1992-02-20 | 87 |
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | HBN | 1990-09-04 | 216 |
9 earlier clearances. See the full list in Caduvo.
Recalls
22 product recalls in 11 recall events; 1 initiated in the last five years. Most recent: 2022-06-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Skytron, Div. the Kmw Group, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Skytron, Div. the Kmw Group, Inc.” (first 1981, latest 2007), across 11 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Skytron, Div. the Kmw Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Skytron, Div. the Kmw Group, Inc. is 61 days.
Which FDA product codes appear under Skytron, Div. the Kmw Group, Inc.?
The most frequent FDA product codes under this applicant name are FSY (Light, Surgical, Ceiling Mounted, 6); GDC (Table, Operating-Room, Electrical, 4); FNM (Mattress, Air Flotation, Alternating Pressure, 1).
Next steps
- See all 19 Skytron, Div. the Kmw Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FSY, Skytron, Div. the Kmw Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.