Nobles-Lai Engineering, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nobles-Lai Engineering, Inc.” (first 1990, latest 1995), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 157 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 |
|---|---|---|---|
| DQI | Withdrawal/Infusion Pump | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GWG | Endoscope, Neurological | 1 | 1 |
| MGZ | Valvulotome | 1 | 1 |
Review panels
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Nobles-Lai Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953554 | NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES | GWG | 1995-10-18 | 82 |
| K933345 | NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC | GCJ | 1994-02-22 | 228 |
| K920026 | NOBLES-LAI IMAGING SYSTEM | FET | 1992-07-28 | 207 |
| K914457 | DISPOSABLE OPTICAL VALVULOTOME | MGZ | 1992-02-05 | 121 |
| K895688 | NOBLES-LAI ENGINEERING INFUSION PUMP | DQI | 1990-02-26 | 157 |
Recalls
openFDA lists no recalls under a recalling firm named Nobles-Lai Engineering, 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 Nobles-Lai Engineering, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via DQI)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via DQI)
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.
- Nobles-Lai (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nobles-Lai Engineering, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nobles-Lai Engineering, Inc.” (first 1990, latest 1995), across 5 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 Nobles-Lai Engineering, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nobles-Lai Engineering, Inc. is 157 days.
Which FDA product codes appear under Nobles-Lai Engineering, Inc.?
The most frequent FDA product codes under this applicant name are DQI (Withdrawal/Infusion Pump, 1); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 5 Nobles-Lai Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQI, Nobles-Lai Engineering, 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.