L H M Ent., Inc.: FDA clearances and approvals
L H M Ent., Inc. has 6 FDA 510(k) clearances (first 1988, latest 1990), across 5 product codes in 4 review panels. Median 510(k) review time: 95 days.
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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 | 2 |
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 1 |
Review panels
- Anesthesiology (2)
- General Hospital (2)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent L H M Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901079 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER | BTO | 1990-05-18 | 72 |
| K901078 | SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE | BTO | 1990-05-18 | 72 |
| K894610 | CUSTOM TRAYS, KITS | FSM | 1990-03-15 | 238 |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | FIH | 1990-02-15 | 17 |
| K894611 | CATHETER CARE KITS | FOZ | 1989-12-15 | 148 |
| K883506 | IRRIGATION KIT | KYZ | 1988-12-13 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named L H M Ent., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of L H M Ent., Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does L H M Ent., Inc. have?
L H M Ent., Inc. has 6 FDA 510(k) clearances (first 1988, latest 1990), across 5 product codes in 4 review panels.
How long does FDA take to clear L H M Ent., Inc.'s 510(k)s?
The median time from FDA receipt to decision across L H M Ent., Inc.'s cleared 510(k)s is 95 days.
What devices does L H M Ent., Inc. make?
Its most frequent FDA product codes are BTO (Tube, Tracheostomy (W/Wo Connector), 2); FIH (Pump, Infusion Or Syringe, Extra-Luminal, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Has L H M Ent., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching L H M Ent., Inc. Related entities may recall under other names.
Next steps
- See all 6 L H M Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTO, L H M Ent., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.