Customed, Inc.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Customed, Inc.” (first 1990, latest 2026), across 18 product codes in 8 review panels. Median 510(k) review time under this name: 87 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 | 1 | 140 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Customed, Inc. took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 11 | 11 |
| LRO | General Surgery Tray | 6 | 6 |
| HHD | Pad, Menstrual, Unscented | 3 | 3 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| LRS | I.V. Start Kit | 2 | 2 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| GJE | Tray, Blood Collection | 1 | 1 |
Plus 8 more product codes.
Review panels
- General Hospital (14)
- General and Plastic Surgery (10)
- Gastroenterology and Urology (4)
- Obstetrics and Gynecology (4)
- Anesthesiology (2)
- Clinical Chemistry (1)
- Ear, Nose and Throat (1)
- Radiology (1)
Most recent Customed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260116 | CustoMED Viewer | LLZ | 2026-06-03 | 140 |
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | KKX | 1998-01-05 | 24 |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | FYA | 1997-12-04 | 195 |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | LRO | 1996-11-25 | 49 |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | KNX | 1996-10-04 | 88 |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | GJE | 1996-09-27 | 87 |
| K961442 | UNIVERSAL DRAINAGE TRAY | FCM | 1996-05-09 | 24 |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | FRG | 1995-10-02 | 56 |
| K950295 | WOUND CLOSURE/LACERATION TRAY | LRO | 1995-04-18 | 84 |
| K942177 | FOLEY CATHETERIZATION TRAY | FCM | 1994-09-08 | 127 |
27 earlier clearances. See the full list in Caduvo.
Recalls
699 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2016-01-07.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Customed, Inc.?
FDA lists 37 510(k) clearances under the applicant name “Customed, Inc.” (first 1990, latest 2026), across 18 product codes in 8 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 Customed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Customed, Inc. is 87 days.
Which FDA product codes appear under Customed, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 11); LRO (General Surgery Tray, 6); HHD (Pad, Menstrual, Unscented, 3).
Next steps
- See all 37 Customed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Customed, 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.