FDA product code · General Hospital
FRGWrap, Sterilization
Product code FRG covers Wrap, Sterilization, a Class II device regulated under 21 CFR 880.6850. FDA has cleared 323 devices in this code, 6 of them in the last 12 months. Median review time across the 323 most recent decisions is 90 days. openFDA lists 50 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.6850
- Review panel
- General Hospital
- Clearances
- 323
What is happening in FRG right now?
FRG (Wrap, Sterilization) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Sterivic Medical Co., Ltd. and Guangdong Maidi Medical Co., Ltd (K251347, K251177, K250306). The code is crowded, scoring 87 of 100 — 171 companies hold a clearance here and 6 arrived in the last 12 months (FRG:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K251347, K251177, K250306 |
| Crowding | Context | FRG:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FRG?
FDA has cleared 323 devices under product code FRG since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. | |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical |
How long does FDA review take for FRG?
The median FDA review time for FRG is 90 days, measured across the 323 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FRG?
openFDA lists 50 recall records against product code FRG. A recall record covers one firm's corrective action and may span many device lots.
Z-1037-2023Open, ClassifiedTurbett Surgical, Inc.
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Z-1038-2023Open, ClassifiedTurbett Surgical, Inc.
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Z-1501-2022TerminatedTurbett Surgical, Inc.
Devices were subject to unapproved rework processes.
Z-1111-2022Open, ClassifiedTurbett Surgical, Inc.
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
Z-0786-2021TerminatedSteris Corporation
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch
Showing the 5 most recently initiated of 50. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FRG?
MAUDE holds 61 adverse-event reports naming product code FRG, 24 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FRG unusual?
FRG does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
20 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered FRG in the last year?
3 companies filed in FRG for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Sterivic Medical Co., Ltd. | K251347 | |
| Guangdong Maidi Medical Co., Ltd. | K251177 | |
| Propper Manufacturing Co., Inc. | K250306 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FRG?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FRG?
Across the 323 most recent decisions, these applicants filed most often in FRG.
| Applicant | Recent clearances |
|---|---|
| Cardinal Health200, LLC | 11 |
| Kimberly-Clark Corp. | 11 |
| Case Medical, Inc. | 9 |
| Medline Industries, Inc. | 9 |
| Custom Pack Reliability | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in FRG file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Medline Industries, LP | 11 | 2 |
| Steris Corporation | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FRG
Get an email the morning anything changes in FRG — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in General Hospital
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.