King & Spalding: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “King & Spalding” (first 1994, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| LZK | Implant, Malar | 2 | 2 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| FZP | Clip, Implantable | 1 | 1 |
| MIB | Elastomer, Silicone Block | 1 | 1 |
Review panels
Most recent King & Spalding 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942423 | NAIS WRIST BLOOD PRESSURE METER | DXN | 1995-02-15 | 271 |
| K942422 | PANASONIC WRIST BLOOD PRESSURE METER | DXN | 1995-02-15 | 271 |
| K945998 | CHIN IMPLANT STYLE I | FWP | 1995-02-07 | 69 |
| K944408 | IMPLANTECH MEDICAL GRADE SILICONE SHEETING | MIB | 1994-11-09 | 62 |
| K942421 | IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT | LZK | 1994-08-08 | 80 |
| K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | LZK | 1994-08-08 | 80 |
| K941972 | HEMO-O-LOK | FZP | 1994-06-29 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named King & Spalding.
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.
- King Diagnostics, Inc. (41 510(k)s)
- King Systems Corp. (18 510(k)s)
- King Dental Corp. (2 510(k)s)
- King Handy Five Corp. (2 510(k)s)
- King'S Sunglass Corp. (2 510(k)s)
- King-Devick Technologies, Inc. (1 510(k)s)
- King I Tech Corporation (1 510(k)s)
- King Kondom Products, Inc. (1 510(k)s)
- King Mfg. Co. (1 510(k)s)
- King'S Bay Intl., Inc. (1 510(k)s)
- King Tool, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under King & Spalding?
FDA lists 7 510(k) clearances under the applicant name “King & Spalding” (first 1994, latest 1995), across 5 product codes in 2 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 King & Spalding?
The median time from FDA receipt to decision across 510(k)s cleared under the name King & Spalding is 80 days.
Which FDA product codes appear under King & Spalding?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); LZK (Implant, Malar, 2); FWP (Prosthesis, Chin, Internal, 1).
Next steps
- See all 7 King & Spalding clearances with predicates and recalls
- Run predicate analysis for product code DXN, King & Spalding'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.