Kmi Kolster Methods, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kmi Kolster Methods, Inc.” (first 1999, latest 2006), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| LHC | Warmer, Irrigation Solution | 1 | 1 |
| QPB | System, Suction, Lipoplasty For Removal | 1 | 1 |
Review panels
Most recent Kmi Kolster Methods, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE | GAW | 2006-10-23 | 249 |
| K043591 | FEATHERLIFT EXTENDED APTOS THREAD | GAW | 2005-03-04 | 66 |
| K012236 | STARS2000 POWER CANNULA | QPB | 2001-11-19 | 125 |
| K010702 | XUB EXTERNAL ULTRASOUND | IMI | 2001-08-09 | 154 |
| K002859 | SSW-STERILE SOLUTION WARMER | LHC | 2000-11-16 | 64 |
| K991203 | IRRIGATION OR INFUSION PUMP K PUMP | FRN | 1999-10-15 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Kmi Kolster Methods, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Kmi Kolster Methods, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kmi Kolster Methods, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kmi Kolster Methods, Inc.” (first 1999, latest 2006), across 5 product codes in 3 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 Kmi Kolster Methods, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kmi Kolster Methods, Inc. is 140 days.
Which FDA product codes appear under Kmi Kolster Methods, Inc.?
The most frequent FDA product codes under this applicant name are GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 2); FRN (Pump, Infusion, 1); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 1).
Next steps
- See all 6 Kmi Kolster Methods, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAW, Kmi Kolster Methods, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.