Lake Medical Products, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Lake Medical Products, Inc.” (first 1987, latest 1995), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| KOD | Catheter, Urological | 2 | 2 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| EXB | Collector, Ostomy | 1 | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 | 1 |
Plus 2 more product codes.
Review panels
- Gastroenterology and Urology (9)
- General Hospital (3)
- Anesthesiology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Lake Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED | FNM | 1995-02-27 | 241 |
| K922730 | LAKE OSTOMY CARE SET | EXB | 1993-12-30 | 573 |
| K905053 | STAGE ZERO AIR FLOTATION BED | IOQ | 1990-11-26 | 18 |
| K901835 | LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) | KNT | 1990-09-05 | 139 |
| K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT | FCM | 1990-08-23 | 79 |
| K902121 | LAKE GASTROSTOMY TUBE | KGC | 1990-07-27 | 77 |
| K884127 | LAKE N/G FEEDING TUBE | KNT | 1989-02-08 | 131 |
| K884128 | LAKE N/G EXTENSION SET | KNT | 1988-12-08 | 69 |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | FCN | 1988-10-12 | 51 |
| K880578 | LAKE DISPOSABLE PROBE COVER | FLL | 1988-03-31 | 50 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lake Medical Products, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lake Region Mfg., Inc. (42 510(k)s)
- Lake Region Medical (17 510(k)s)
- Lake Consumer Products, Inc. (1 510(k)s)
- Lake Pharmaceutical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lake Medical Products, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Lake Medical Products, Inc.” (first 1987, latest 1995), across 12 product codes in 5 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 Lake Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lake Medical Products, Inc. is 77 days.
Which FDA product codes appear under Lake Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 3); KOD (Catheter, Urological, 2); CBT (Arterial Blood Sampling Kit, 1).
Next steps
- See all 15 Lake Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Lake Medical Products, 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.