Custom Pack Reliability: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Custom Pack Reliability” (first 1996, latest 1996), across 14 product codes in 6 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 7 | 7 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
Plus 4 more product codes.
Review panels
- General Hospital (12)
- Gastroenterology and Urology (3)
- Obstetrics and Gynecology (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
Most recent Custom Pack Reliability 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960205 | CPR TRACHEOTOMY CARE TRAY | BTO | 1996-08-27 | 224 |
| K960243 | CPR C-SECTION DELIVERY PACK | MLS | 1996-05-23 | 128 |
| K960239 | CPR D & C TRAY | HHK | 1996-05-23 | 128 |
| K960216 | CPR SUCTION CATHETER KIT | JOL | 1996-04-15 | 90 |
| K960213 | CPR TOTAL HIP PACK | FRG | 1996-04-12 | 87 |
| K960211 | CPR TOTAL KNEE PACK | FRG | 1996-04-12 | 87 |
| K960210 | CPR ORTHO HAND PACK | FRG | 1996-04-12 | 87 |
| K960206 | CPR DRESSING CHANGE TRAY | FRG | 1996-04-12 | 87 |
| K960209 | CPR HEART PACK | GAW | 1996-04-04 | 79 |
| K960215 | CPR URETHRAL CATHETER TRAY | FCM | 1996-04-01 | 76 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Custom Pack Reliability.
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.
- Custom Medical Products, Ltd. (14 510(k)s)
- Custom Spine, Inc. (14 510(k)s)
- Custom Services Intl., Inc. (9 510(k)s)
- Custom Orthopaedic Solutions, Inc. (8 510(k)s)
- Custom Ultrasonics (6 510(k)s)
- Custom Optical Frames, Inc. (4 510(k)s)
- Custom Surgical Products, Inc. (4 510(k)s)
- Custom Medical, Inc. (3 510(k)s)
- Custom Medical Devices Intl., Inc. (3 510(k)s)
- Custom Cardio Components (2 510(k)s)
- Custom Medical Plastics, Inc. (2 510(k)s)
- Custom Assemblies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Custom Pack Reliability?
FDA lists 21 510(k) clearances under the applicant name “Custom Pack Reliability” (first 1996, latest 1996), across 14 product codes in 6 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 Custom Pack Reliability?
The median time from FDA receipt to decision across 510(k)s cleared under the name Custom Pack Reliability is 76 days.
Which FDA product codes appear under Custom Pack Reliability?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 7); FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 2); BTO (Tube, Tracheostomy (W/Wo Connector), 1).
Next steps
- See all 21 Custom Pack Reliability clearances with predicates and recalls
- Run predicate analysis for product code FRG, Custom Pack Reliability'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.